Cleared Traditional

K921862 - BACTON(TM), AUTO-APO B REAGENT

K921862 is an FDA 510(k) clearance for BACTON(TM), manufactured by Bacton Assay Systems, Inc.. The device is a Class 1 Immunology device with product code MSJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K921862 · Bacton Assay Systems, Inc. · Immunology device
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Jun 1992
Decision
69d
Days
Class 1
Risk

K921862 is an FDA 510(k) clearance for the BACTON(TM), AUTO-APO B REAGENT. Classified as Apolipoproteins (product code MSJ), Class I - General Controls.

Submitted by Bacton Assay Systems, Inc. (San Marcos, US). The FDA issued a Cleared decision on June 22, 1992 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1475 - 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 Bacton Assay Systems, Inc. devices

FDA 510(k) Submission Details - K921862

510(k) Number K921862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1992
Decision Date June 22, 1992
Days to Decision 69 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 105d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

MSJ Device Classification - Class 1, General Controls

Product Code MSJ Apolipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MSJ Apolipoproteins

All 38
Devices cleared under the same product code (MSJ) and FDA review panel - the closest regulatory comparables to K921862.
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · Nichols Institute Diagnostics · Dec 1992
IL TEST APOLIPOROTEIN B (APO B)
K923080 · Instrumentation Laboratory CO · Oct 1992
IL TEST APOLIPOPROTEIN A1
K923087 · Instrumentation Laboratory CO · Oct 1992
APOLIPOPROTEIN TEST SYSTEM
K921037 · Baxter Diagnostics, Inc. · May 1992
REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1
K914069 · Medical Analysis Systems, Inc. · Oct 1991
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
K912749 · Medical Analysis Systems, Inc. · Sep 1991