Cleared Traditional

K903215 - LABMASTER BETA-2-MICROGLOBULIN ELISA TEST KIT TM

K903215 is an FDA 510(k) clearance for LABMASTER BETA-2-MICROGLOBULIN ELISA TE..., manufactured by Bioproducts For Science, Inc.. The device is a Class 2 Chemistry device with product code JZG cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K903215 · Bioproducts For Science, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K903215

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.

JZG Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K903215.
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · Diagnostic Products Corp. · Jul 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · Behring Diagnostics, Inc. · Apr 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · Diagnostic Products Corp. · Mar 1991
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · Pharmacia, Inc. · Aug 1990
AIA-PACK BMG
K900440 · Tosoh Medics, Inc. · Feb 1990
PHARMACIA B2 MICRO EIA
K900449 · Pharmacia, Inc. · Feb 1990