Atlas FDA

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

FDA 510(k) clearance K994419 · decided 2000-06-28

Clearance details

K-number
K994419
Device name
FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM
Applicant
Qualisys Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
1999-12-29
Decision date
2000-06-28
Days to decision
182 days
Clearance type
Traditional
Product code
LTJ
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Carlsbad, CA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (K251630)Siemens Healthcare Diagnostics, Inc.2026-01-05
FREND PSA PLUS (reagent cartridge) (K162378)Nanoentek USA, Inc.2017-05-17
FREND PSA PLUS (REAGENT CARTRIDGE) (K124056)Nanoentek, Inc.2013-05-29
TPSA FLEX REAGENT CARTRIDGE (K031343)Dade Behring, Inc.2003-05-15
PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022177)Bayer Diagnostics Corp.2002-12-17
COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM (K022288)Bayer Corp.2002-12-17
VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 (K010550)bioMerieux, Inc.2001-04-24
DIMENSION PSA FLEX REAGENT CARTRIDGE (K003963)Dade Behring, Inc.2001-02-28
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY (K002376)Bayer Corp.2000-10-26
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER (K003094)Qualigen, Inc.2000-10-25
TOTAL PSA MICROTITER ELISA (K002121)Oncogene Science, Inc.2000-08-30
COMPLEXED PSA MICROTITER ELISA (K002313)Oncogene Science, Inc.2000-08-30

Recalls involving this device

RecordFirmDate
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. F recall (Z-0547-2014)Qualigen Inc2013-12-19
FastPack(R) Total PSA Immunoassay; Catalog #: 25000001 Is a paramagnetic particle immunoas recall (Z-0500-2009)Qualigen Inc2008-12-22