Cleared Traditional

K863352 - PRECIMAT IGA

K863352 is an FDA 510(k) clearance for PRECIMAT IGA, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code CZP cleared through the Traditional 510(k) pathway after a 19-day FDA review.

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

FDA 510(k) Submission Details - K863352

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.

CZP Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K863352.
WAKO(TM) IGA-HA DIRECT
K880803 · Wako Chemicals USA, Inc. · Mar 1988
IMMUNOGLOBULINS A
K873869 · Unipath , Ltd. · Oct 1987
QM300 IGA, ANTIGEN, ANTISERUM, CONTROL
K871940 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1987
TINA-QUANT(R) IGA
K862763 · Boehringer Mannheim Corp. · Sep 1986
TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT
K855046 · Abbott Laboratories · Aug 1986
DAKO ITA, IMMUNOGLOBULIN A (IGA)
K862183 · Dako Corp. · Aug 1986