Cleared Traditional

PRECIMAT (R) IGA, G, M (K863352) - FDA 510(k) Clearance

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

K863352 · Boehringer Mannheim Corp. · Immunology device
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Sep 1986
Decision
19d
Days
Class 2
Risk

K863352 is an FDA 510(k) clearance for the PRECIMAT (R) IGA, G, M. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 17, 1986 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 K863352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1986
Decision Date September 17, 1986
Days to Decision 19 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
85d faster than avg
Panel avg: 104d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CZP Iga, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K863352.
IL TEST IMMUNOGLOBULIN A
K920014 · Instrumentation Laboratory CO · Jun 1992
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · Helena Laboratories · Feb 1990
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492 · Technicon Instruments Corp. · Sep 1988
TINA-QUANT(R) IGA
K862763 · Boehringer Mannheim Corp. · Sep 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · Abbott Laboratories · Aug 1986
TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG
K842468 · Miles Laboratories, Inc. · Aug 1984