Cleared Traditional

K802308 - T/K (ATA/AMA) UNIVERSAL BIOPAK

K802308 is the FDA 510(k) clearance for T/K (ATA/AMA) UNIVERSAL BIOPAK by Bioware Products. It is a Class 2 Immunology device (product code DBM) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K802308 · Bioware Products · Immunology device
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Dec 1980
Decision
69d
Days
Class 2
Risk

K802308 is an FDA 510(k) clearance for the T/K (ATA/AMA) UNIVERSAL BIOPAK. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Bioware Products (Walker, US). The FDA issued a Cleared decision on December 1, 1980 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 Bioware Products devices

Submission Details

510(k) Number K802308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1980
Decision Date December 01, 1980
Days to Decision 69 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 104d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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 - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 16
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K802308.
AYNELISA M2-ANTIBODIES
K930143 · Elias U.S.A., Inc. · May 1993
AUTOANTIBODY SCREEN TEST SYSTEM
K831358 · Zeus Scientific, Inc. · Jun 1983
KALLESTAD HEP-2 CELL LINE SUBSTRATE
K810863 · Kallestad Laboratories, Inc. · Apr 1981
AFT TM SYSTEM ANTIMITOCHONDRIAL ANTIBODY
K800821 · Calbiochem-Behring Corp. · Apr 1980
IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT
K800229 · Clinical Sciences, Inc. · Feb 1980
TEST KIT, IIF-AMA
K790295 · Medica Corp. · May 1979