Atlas FDA

JWY

441 FDA 510(k) clearances · Product code

69 daysmedian time to decision
175 days90th percentile
441clearances measured

FDA profile

Official device name
Manual Antimicrobial Susceptibility Test Systems
Device class
Class II (moderate risk)
Regulation
21 CFR 866.1640
Medical specialty
Microbiology
Flags
Third-party review eligible
Adverse events (MAUDE)
2015: 11 · 2016: 20 · 2018: 13 · 2020: 20 · 2021: 41
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ETEST Gepotidacin (GEP) (0.016-256 µg/mL) (K260447)bioMérieux SA2026-04-21
MTS Gepotidacin 0.016-256 µg/mL (K260696)Liofilchem s.r.l.2026-04-17
MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL (K252114)Liofilchem s.r.l.2025-10-02
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL (K252062)Thermo Fisher Scientific2025-09-25
The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL (K250575)Thermo Fisher Scientific2025-09-05
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL (K252014)Thermo Fisher Scientific2025-08-28
MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) (K251580)Liofilchem s.r.l.2025-08-20
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL (K250990)Thermo Fisher Scientific2025-06-30
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. (K242843)Thermo Fisher Scientific2025-06-20
ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) (K250856)Biomérieux2025-06-12
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL (K242659)Thermo Fisher Scientific2025-05-22
ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) (K250274)Biomerieux S.A.2025-04-30
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL (K242658)Thermo Fisher Scientific2025-04-15
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL (K243201)Thermo Fisher Scientific2025-02-10
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL (K242905)Thermo Fisher Scientific2025-02-10
MTS Ceftobiprole 0.002-32 µg/mL (K243202)Liofilchem s.r.l.2025-01-30
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL (K243169)Thermo Fisher Scientific2024-12-19
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL (K242653)Thermo Fisher Scientific2024-12-05
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL (K242657)Thermo Fisher Scientific2024-11-26
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. (K242021)Thermo Fisher Scientific2024-10-09
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. (K241967)Thermo Fisher Scientific2024-10-01
The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. (K240445)Thermo Fisher Scientific2024-05-16
Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml (K232310)Thermo Fisher Scientific2023-10-31
ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD (K232395)Biomérieux2023-10-05
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml (K231988)Thermo Fisher Scientific2023-08-30
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL (K231994)Thermo Fisher Scientific2023-08-25
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) (K230935)Thermo Fisher Scientific2023-06-30
ComASP Cefiderocol 0.008-128 (K230479)Liofilchem s.r.l.2023-05-18
Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) (K223844)Thermo Fisher Scientific2023-03-21
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml (K203741)Thermo Fisher Scientific2021-12-20
ETEST Fosfomycin (FO) (0.032-512 µg/mL) (K210757)Biomerieux S.A.2021-11-12
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL (K211672)Liofilchem s.r.l.2021-10-20
Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) (K202612)Thermo Fisher Scientific2021-07-23
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) (K202423)Beckman Coulter, Inc.2021-05-18
ETEST Plazomicin (PLZ) (0.016-256 µg/mL) (K200512)Biomérieux SA2020-05-07
MTS Lefamulin 0.016- 256 µg/mL (K200308)Liofilchem S. R. 1.2020-04-06
MTS Omadacycline 0.002 - 32 ug/mL (K200180)Liofilchem s.r.l.2020-03-20
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml (K193538)Thermo Fisher Scientific2020-03-12
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL (K193024)Thermo Fisher Scientific2020-01-08
ETEST Delafloxacin (DFX) (0.002-32 µg/mL) (K192738)Biomerieux S.A.2019-11-26
MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) (K192355)Beckman Coulter, Inc.2019-11-14
Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml (K192729)Thermo Fisher Scientific2019-11-06
MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL (K192345)Liofilchem s.r.l.2019-10-31
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL (K192250)Thermo Fisher Scientific2019-10-16
ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) (K192050)Biomerieux S.A.2019-09-27
MTS Imipenem 0.016-256 µg/mL (K191908)Liofilchem s.r.l.2019-09-04
MTS Imipenem-relebactam 0.002/4-32/4 µg/mL (K191809)Liofilchem s.r.l.2019-08-23
ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) (K191953)Biomerieux S.A.2019-08-22
MTS Doxycycline 0.016 - 256 µg/mL (K190914)Liofilchem s.r.l.2019-05-29
ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) (K190154)Biomerieux S.A.2019-05-01
MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) (K190109)Beckman Coulter, Inc.2019-04-18
MTS Gentamicin 0.016 - 256 µg/mL (K190252)Liofilchem s.r.l.2019-03-22
MTS Ciprofloxacin 0.002 - 32 µg/mL (K183527)Liofilchem s.r.l.2019-03-19
Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL (K183324)Thermo Fisher Scientific2019-02-15
ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) (K183031)Biomerieux S.A.2019-01-11
MTS Tetracycline 0.016 - 256 ug/mL (K183140)Liofilchem s.r.l.2019-01-11
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml (K183033)Thermo Fisher Scientific2019-01-04
MTS Levofloxacin 0.002 - 32 µg/mL (K183115)Liofilchem s.r.l.2018-12-20
MTS Omadacycline 0.002-32 µg/mL (K182922)Liofilchem s.r.l.2018-12-14
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL (K182797)Thermo Fisher Scientific2018-11-30
MTS Eravacycline 0.002 - 32 µg/mL (K182557)Liofilchem s.r.l.2018-11-02
MTS Penicillin 0.002- 32 µg/mL (K181889)Liofilchem s.r.l.2018-09-13
Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL (K181946)Thermo Fisher Scientific2018-08-08
MTS Plazomicin 0.016-256 µg/mL (K181708)Liofilchem s.r.l.2018-07-31
ETEST Telavancin (TLA) (0.002-32 ug/mL) (K180936)Biomerieux S.A.2018-07-03
Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL (K180886)Liofilchem s.r.l.2018-05-18
Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL (K180339)Liofilchem s.r.l.2018-04-04
Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL (K180330)Liofilchem s.r.l.2018-03-15
Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL (K173817)Liofilchem s.r.l.2018-02-28
Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL (K173307)Liofilchem s.r.l.2017-12-19
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL (K173209)Thermo Fisher Scientific2017-12-01
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 mg/mL. (K172542)Liofilchem s.r.l.2017-10-23
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.004-8 ug/mL (K172454)Thermo Fisher Scientific2017-10-13
Liofilchem MIC Test Strip (MTS), Erythromycin 0.016 - 256 µg/mL (K172109)Liofilchem s.r.l.2017-09-27
Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) (K172150)bioMerieux, Inc.2017-09-15
The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8µg/mL (K172274)Thermo Fisher Scientific2017-08-30
Liofilchem MIC Test Strip (MTS)- Delafloxacin 0.002 - 32 µg/mL (K171906)Liofilchem s.r.l.2017-08-01
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.0005 – 8 ug/mL (K171870)Thermo Fisher Scientific2017-08-01
Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL (K170772)Liofilchem s.r.l.2017-06-07
Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) (K170670)bioMerieux, Inc.2017-05-31
Liofilchem MIC Test Strip (MTS)- Tedizolid 0.002 - 32 µg/mL (K170892)Liofilchem s.r.l.2017-05-25
Liofilchem MIC Test Strip (MTS) Telavancin 0.016 - 256.0 µg/mL (K163517)Liofilchem s.r.l.2017-03-14
Liofilchem MIC Test Strip (MTS) Ceftazidime 0.016 - 256.0 µg/mL (K163298)Liofilchem s.r.l.2017-02-22
Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml (K162854)Liofilchem s.r.l.2016-12-19
Liofilchem MIC Test Strip (MTS)- Ceftolozane/Tazobactam 0.016/4 - 256/4 mcg/mL (K161175)Liofilchem s.r.l.2016-07-12
Liofilchem MIC Test Strip (MTS) -Dalbavancin at 0.002 - 32 ug/ml (K153569)Liofilchem s.r.l.2016-06-22
Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL (K153687)Liofilchem s.r.l.2016-03-31
The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftazidime/Avibactam in the dilutions range of 0.015/4 - 32/4 ug/mL (K152774)Thermo Fisher Scientific2015-12-21
Etest Ceftaroline (0.002 - 32ug/ml) (K151873)Biomerieux S.A.2015-10-07
MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) (K152346)Beckman Coulter, Inc.2015-09-16
Sensititre 18-24 hours MIC or BP Susceptibility System with Ceftolozane/tazobactam (0.03/4- 64/4ug/mL) (K150556)Thermo Fisher Scientific2015-08-28
Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Dalbavancin (0.0005 - 2ug/mL) (K150236)Thermo Fisher Scientific2015-07-27
Sensititre Susceptibility plates (K143288)Thermo Fisher Scientific2015-04-01
The Sensititre HP MIC Susceptibility plate with Oritavancin (0.0005-8mcg/ml) (K143526)Thermo Fisher Scientific2015-03-05
Sensititre HP MIC Susceptibility Plate with Tedizolid (0.002-4 mcg/ml) (K142338)Thermo Fisher Scientific2015-03-02
Sensititre Susceptibility Plates (K143381)Thermo Fisher Scientific2015-02-19
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K142151)Thermo Fisher Scientific2014-12-23
SENSITITRE SUSCEPTIBILITY PLATES (K141651)Thermo Fisher Scientific2014-10-21
SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES (K133847)Thermo Fisher Scientific2014-08-01
SENSITITRE SUSCEPTIBILITY PLATES (K141000)Thermo Fisher Scientific2014-07-16
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