Atlas FDA

Tina-quant Cardiac high sensitivity CRP III

FDA 510(k) clearance K260026 · decided 2026-04-02

Clearance details

K-number
K260026
Device name
Tina-quant Cardiac high sensitivity CRP III
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2026-01-05
Decision date
2026-04-02
Days to decision
87 days
Clearance type
Traditional
Product code
NQD
Device class
2
Regulation number
866.5270
Medical specialty
Immunology
Advisory committee
Immunology
Location
Indianapolis, IN, 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® CH High Sensitivity C-Reactive Protein 2 (hCRP2) (K233242)Siemens Healthcare Diagnostics, Inc.2024-01-18
CardioPhase® hsCRP (K212559)Siemens Healthcare Diagnostics Products GmbH2022-12-16
CRP Vario (K173833)SENTINEL CH. SpA2018-09-27
ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS (K081294)Siemens Healthcare Diagnostics, Inc.2008-07-29
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT (K071002)Beckman Coulter, Inc.2007-06-21
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT (K070626)Beckman Coulter, Inc.2007-05-04
IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) (K071017)Siemens Medical Solutions Diagnostics2007-05-02
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK (K062924)Dade Behring, Inc.2006-12-26
IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRP (K063057)Diagnostic Products Corporation2006-12-22
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH (K061802)Dade Behring, Inc.2006-09-11
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK (K060369)Dade Behring, Inc.2006-05-04
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS (K053603)Roche Diagnostics Corp.2006-02-09

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01