Cleared Traditional

K930621 - TINA-QUANT CRP

K930621 is an FDA 510(k) clearance for TINA-QUANT CRP, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DCK cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K930621 · Boehringer Mannheim Corp. · Immunology device
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Optimized for regulatory review, auditing and printing
Mar 1993
Decision
30d
Days
Class 2
Risk

K930621 is an FDA 510(k) clearance for the TINA-QUANT CRP. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 10, 1993 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K930621

510(k) Number K930621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1993
Decision Date March 10, 1993
Days to Decision 30 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 104d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 87
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K930621.
DUPONT DIMENSION C-REACTIVE PROTEIN METHOD
K945280 · Dupont Medical Products · Mar 1995
HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD)
K944288 · Hemagen Diagnostics, Inc. · Oct 1994
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
VIGIL II
K920845 · Beckman Instruments, Inc. · Dec 1992
TIA CRP TEST KIT
K914155 · Crestat Diagnostics, Inc. · Jan 1992
HUMAN C-REACTIVE PROTEIN RID KIT
K905633 · The Binding Site, Ltd. · Jul 1991