Cleared Traditional

K854502 - ALT(OPTIMIZED) REAGENT

K854502 is the FDA 510(k) clearance for ALT(OPTIMIZED) REAGENT by Sigma Diagnostics, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K854502 · Sigma Diagnostics, Inc. · Chemistry device
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Nov 1985
Decision
13d
Days
Class 1
Risk

K854502 is an FDA 510(k) clearance for the ALT(OPTIMIZED) REAGENT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 25, 1985 after a review of 13 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K854502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1985
Decision Date November 25, 1985
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CKA Nadh Oxidation/nad Reduction, 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.

Regulatory Peers - CKA Nadh Oxidation/nad Reduction, Alt/sgpt

All 97
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K854502.
VISION SGPT (ALT)
K861002 · Abbott Laboratories · Apr 1986
ALT(GPT) (ALANINE AMINOTRANSFERASE) REAGENT
K860727 · Trace Scientific , Ltd. · Apr 1986
IN VITRO TEST DETERMINATION OF SGPT(ALT)
K854186 · Clinical Data, Inc. · Dec 1985
HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE
K852867 · Hi Chem, Inc. · Aug 1985
AMRESCO FLOW PAC SMA PHOSPHATE BUFFER CONCENTRATE
K851923 · Amresco, Inc. · May 1985
ROCHE REAGENT FOR ALT
K843111 · Roche Diagnostic Systems, Inc. · Oct 1984