Cleared Traditional

K831358 - AUTOANTIBODY SCREEN TEST SYSTEM

K831358 is an FDA 510(k) clearance for AUTOANTIBODY SCREEN TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code DBM cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K831358 · Zeus Scientific, Inc. · Microbiology device
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Jun 1983
Decision
50d
Days
Class 2
Risk

K831358 is an FDA 510(k) clearance for the AUTOANTIBODY SCREEN TEST SYSTEM. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 15, 1983 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5090 - the FDA microbiology 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K831358

510(k) Number K831358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1983
Decision Date June 15, 1983
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 102d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBM Device Classification - Class 2, Special Controls

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 Microbiology 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 K831358.
VARELISA M2 ANTIBODIES
K945607 · Elias U.S.A., Inc. · Jan 1995
AYNELISA M2-ANTIBODIES
K930143 · Elias U.S.A., Inc. · May 1993
DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT
K921183 · Shield Diagnostics, Ltd. · Jun 1992
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