Cleared Traditional

K895496 - BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUN...

K895496 is the FDA 510(k) clearance for BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUN... by Incstar Corp.. It is a Class 2 Chemistry device (product code JZG) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K895496 · Incstar Corp. · Chemistry device
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Oct 1989
Decision
69d
Days
Class 2
Risk

K895496 is an FDA 510(k) clearance for the BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on October 17, 1989 after a review of 69 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 Incstar Corp. devices

Submission Details

510(k) Number K895496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1989
Decision Date October 17, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K895496.
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
IMX B2-MICROGLOBULIN
K890421 · Abbott Laboratories · Mar 1989
PHARMACIA B2-MICRO RIA
K880719 · Pharmacia, Inc. · Apr 1988
ABBOTT B2-MICROGLOBULIN RIA
K864130 · Abbott Laboratories · Nov 1986