Cleared Traditional

K860216 - SGOT (AST) REAGENT SET

K860216 is an FDA 510(k) clearance for SGOT (AST) REAGENT SET, manufactured by Sterling Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code CIQ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K860216 · Sterling Diagnostics, Inc. · Chemistry device
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Apr 1986
Decision
71d
Days
Class 2
Risk

K860216 is an FDA 510(k) clearance for the SGOT (AST) REAGENT SET. Classified as Diazo, Ast/sgot (product code CIQ), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 71 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 Sterling Diagnostics, Inc. devices

FDA 510(k) Submission Details - K860216

510(k) Number K860216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date April 03, 1986
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
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 K860216.
ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)
K881173 · Tech-Co, Inc. · Jun 1988
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