FDA Product Code NQD: Cardiac C-reactive Protein, Antigen, Antiserum, And Control
In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
Leading manufacturers include Dade Behring, Inc., Roche Diagnostics Corp. and Beckman Coulter, Inc..
19
Total
19
Cleared
100d
Avg days
2004
Since
Declining activity -
1 submissions in the last 2 years
vs 2 in the prior period
Consistent review times:
87d avg (recent)
FDA 510(k) Cleared Cardiac C-reactive Protein, Antigen, Antiserum, And Control Devices (Product Code NQD)
19 devices
Cleared
Apr 02, 2026
Tina-quant Cardiac high sensitivity CRP III
Roche Diagnostics
Chemistry
87d
Cleared
Jan 18, 2024
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
Siemens Healthcare Diagnostics, Inc.
Chemistry
112d
Cleared
Dec 16, 2022
CardioPhase® hsCRP
Siemens Healthcare Diagnostics Products GmbH
Chemistry
490d
Cleared
Sep 27, 2018
CRP Vario
SENTINEL CH. SpA
Chemistry
283d
Cleared
Jun 21, 2007
IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT
Beckman Coulter, Inc.
Chemistry
73d
Cleared
May 04, 2007
SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT
Beckman Coulter, Inc.
Chemistry
59d
Cleared
Dec 26, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK
Dade Behring, Inc.
Chemistry
89d
Cleared
Sep 11, 2006
DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH
Dade Behring, Inc.
Chemistry
76d
Cleared
May 04, 2006
STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK
Dade Behring, Inc.
Chemistry
80d
Cleared
Feb 09, 2006
C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
Roche Diagnostics Corp.
Chemistry
48d
Cleared
Dec 23, 2005
DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
Chemistry
49d
Cleared
Oct 29, 2004
TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
Roche Diagnostics Corp.
Chemistry
46d
Cleared
Jan 22, 2004
N HIGH SENSITIVITY CRP
Dade Behring, Inc.
Chemistry
36d
About Product Code NQD - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code NQD since 2004, with 19 receiving FDA clearance (average review time: 100 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA 510(k) Review Time - NQD Product Code
FDA review times for NQD submissions have been consistent, averaging 87 days recently vs 101 days historically.
NQD devices are reviewed by the Chemistry panel. Browse all Chemistry devices →