Cleared Traditional

TINA-QUANT CRP (K930621) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K930621 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
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

Submission Details

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.

Device Classification

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 39
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K930621.
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
K962373 · Behring Diagnostics, Inc. · Jul 1996
N LATEX CRP MONO REAGENT
K962523 · Behring Diagnostics, Inc. · Jul 1996
N/T RHEUMATOLOGY CONTROL SL/1, SL/2
K944375 · Behring Diagnostics, Inc. · Oct 1994
VIGIL II
K920845 · Beckman Instruments, Inc. · Dec 1992
TECHNICON DPA-1 (TM) CRP METHOD
K892198 · Technicon Instruments Corp. · May 1989
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1988