Cleared Traditional

K881173 - ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)

K881173 is an FDA 510(k) clearance for ASPARTATE AMINOTRANSFERASE (COLORIMETRI..., manufactured by Tech-Co, Inc.. The device is a Class 2 Chemistry device with product code CIQ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K881173 · Tech-Co, Inc. · Chemistry device
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Jun 1988
Decision
81d
Days
Class 2
Risk

K881173 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD). Classified as Diazo, Ast/sgot (product code CIQ), Class II - Special Controls.

Submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on June 7, 1988 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 Tech-Co, Inc. devices

FDA 510(k) Submission Details - K881173

510(k) Number K881173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1988
Decision Date June 07, 1988
Days to Decision 81 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
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIQ Device Classification - Class 2, Special Controls

Product Code CIQ Diazo, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIQ Diazo, Ast/sgot

Devices cleared under the same product code (CIQ) and FDA review panel - the closest regulatory comparables to K881173.
SGOT (AST) REAGENT SET
K860216 · Sterling Diagnostics, Inc. · Apr 1986
GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET
K855189 · Technostics Intl. · Jan 1986
SGOT REAGENT SET
K841065 · Medical Specialties, Inc. · May 1984
SGOT REAGENT SET
K821209 · Omega Medical Electronics · Jul 1982
SGOT REAGENT SET
K820466 · Anco Medical Reagents & Assoc. · Mar 1982