Cleared Traditional

BIOTRACK ALT TEST CARTRIDGE (K895128) - FDA 510(k) Clearance

Class I Chemistry device.

K895128 · Biotrack, Inc. · Chemistry device
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Oct 1989
Decision
50d
Days
Class 1
Risk

K895128 is an FDA 510(k) clearance for the BIOTRACK ALT TEST CARTRIDGE. Classified as Diazo, Alt/sgpt (product code CJJ), Class I - General Controls.

Submitted by Biotrack, Inc. (Mountain View, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1030 - 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 Biotrack, Inc. devices

Submission Details

510(k) Number K895128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1989
Decision Date October 06, 1989
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CJJ Diazo, Alt/sgpt
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1030
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.