Cleared Traditional

K841060 - SGPT REAGENT SET

K841060 is the FDA 510(k) clearance for SGPT REAGENT SET by Medical Specialties, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K841060 · Medical Specialties, Inc. · Chemistry device
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May 1984
Decision
50d
Days
Class 1
Risk

K841060 is an FDA 510(k) clearance for the SGPT REAGENT SET. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984 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 Medical Specialties, Inc. devices

Submission Details

510(k) Number K841060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date May 01, 1984
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K841060.
SYSTEMATE GPT 67209
K843334 · Em Diagnostic Systems, Inc. · Sep 1984
SIGMA 59-UV FOR ALANINE AMINOTRANSFER
K842564 · Sigma Chemical Co. · Aug 1984
ALANINE AMINOTRANSFERASE ASSAY KIT
K842241 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984
PARAMAX ALANINE AMINOTRANSFERASE
K840705 · American Dade · Mar 1984
ALT -LTS
K832639 · Electro-Nucleonics Laboratories, Inc. · Sep 1983
FLOW-PAC SGPT REAGENT
K830959 · Amresco, Inc. · May 1983