Cleared Traditional

PRECIMAT(R) C4 (K871023) - FDA 510(k) Clearance

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

K871023 · Boehringer Mannheim Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1987
Decision
59d
Days
Class 2
Risk

K871023 is an FDA 510(k) clearance for the PRECIMAT(R) C4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 14, 1987 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 K871023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1987
Decision Date May 14, 1987
Days to Decision 59 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
45d faster than avg
Panel avg: 104d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DBI Complement C4, Antigen, Antiserum, Control

All 9
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K871023.
QUANTEX C4
K962198 · Instrumentation Laboratory CO · Sep 1996
IL TEST COMPLEMENT 4
K920010 · Instrumentation Laboratory CO · Mar 1992
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621 · Technicon Instruments Corp. · Jul 1988
TINA-QUANT(R) (A) C4
K870931 · Boehringer Mannheim Corp. · Mar 1987
C4 ANTIGEN ANTIBODY CONTROL
K834605 · Technicon Instruments Corp. · Jan 1984