Cleared Traditional

PRECIMAT(R) CRP (K871055) - FDA 510(k) Clearance

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

K871055 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
50d
Days
Class 2
Risk

K871055 is an FDA 510(k) clearance for the PRECIMAT(R) 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 May 6, 1987 after a review of 50 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 K871055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1987
Decision Date May 06, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 104d · This submission: 50d
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 K871055.
DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR
K884101 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1988
VISION(R) CRP
K875345 · Abbott Laboratories · Mar 1988
TINA-QUANT [A] CRP
K871895 · Boehringer Mannheim Corp. · Jun 1987
VISION(TM) CRP
K864131 · Abbott Laboratories · Mar 1987
C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS
K863628 · Technicon Instruments Corp. · Oct 1986
ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST
K863328 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1986