Cleared Traditional

K790522 - COULTER ACCU-ZYME II GPT REAGENT

K790522 is the FDA 510(k) clearance for COULTER ACCU-ZYME II GPT REAGENT by Coulter Electronics, Inc.. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K790522 · Coulter Electronics, Inc. · Chemistry device
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May 1979
Decision
53d
Days
Class 1
Risk

K790522 is an FDA 510(k) clearance for the COULTER ACCU-ZYME II GPT REAGENT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Coulter Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1979 after a review of 53 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K790522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 1979
Decision Date May 01, 1979
Days to Decision 53 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
35d faster than avg
Panel avg: 88d · This submission: 53d
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 K790522.
SGPT REAGENT SET MODIFICATION
K791641 · American Monitor Corp. · Sep 1979
SPIN CHEM, DETERMINATION OF ALT (GPT)
K791083 · Smithkline Diagnostics, Inc. · Jul 1979
PLUS CHEM, DETERMINATION OF ALT (GPT)
K791084 · Smithkline Diagnostics, Inc. · Jul 1979
SERUM, GLUTAMIC-PYRUVIC
K790016 · Fisher Scientific Co., LLC · Feb 1979
REAGENT SET, SGPT SERUM GLUTAMIC
K781726 · Medical Analysis Systems, Inc. · Nov 1978
SGPT/ALT REAGENT SYSTEM
K780791 · American Monitor Corp. · Jun 1978