Cleared Traditional

K812632 - ACA IMMUNOGLOBIN M TEST PACK

K812632 is the FDA 510(k) clearance for ACA IMMUNOGLOBIN M TEST PACK by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812632 · E.I. Dupont DE Nemours & Co., Inc. · Immunology device
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Sep 1981
Decision
14d
Days
Class 2
Risk

K812632 is an FDA 510(k) clearance for the ACA IMMUNOGLOBIN M TEST PACK. Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 29, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K812632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1981
Decision Date September 29, 1981
Days to Decision 14 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
90d faster than avg
Panel avg: 104d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFT Igm, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K812632.
AMER. HISTO-ID SYS PRIMARY IGM S7920-31
K842327 · Bartels Immunodiagnostic Supplies, Inc. · Aug 1984
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · Isolab, Inc. · Mar 1983
AIM SYSTEM (FOR IGM)
K811124 · Icl Scientific · May 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · Icl Scientific · Jan 1981
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282 · J.T. Baker Chemical Co. · Jun 1980