Cleared Traditional

LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM (K903215) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K903215 · Bioproducts For Science, Inc. · Chemistry device
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Sep 1990
Decision
64d
Days
Class 2
Risk

K903215 is an FDA 510(k) clearance for the LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Bioproducts For Science, Inc. (Indianapolis, US). The FDA issued a Cleared decision on September 25, 1990 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5630 - the FDA in vitro diagnostics and chemistry 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 Bioproducts For Science, Inc. devices

Submission Details

510(k) Number K903215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1990
Decision Date September 25, 1990
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 Chemistry devices follow this clearance model.

Regulatory Peers - JZG System, Test, Beta-2-microglobulin Immunological

All 13
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K903215.
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · Diagnostic Products Corp. · Jul 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · Diagnostic Products Corp. · Mar 1991
IMX B2-MICROGLOBULIN
K890421 · Abbott Laboratories · Mar 1989
ABBOTT B2-MICROGLOBULIN RIA
K864130 · Abbott Laboratories · Nov 1986