Cleared Traditional

K812591 - ULTRA ZYME PLUS GPT, #64956, 65035 & 36

K812591 is an FDA 510(k) clearance for ULTRA ZYME PLUS GPT, manufactured by Harleco. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K812591 · Harleco · Chemistry device
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Sep 1981
Decision
13d
Days
Class 1
Risk

K812591 is an FDA 510(k) clearance for the ULTRA ZYME PLUS GPT, #64956, 65035 & 36. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981 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 Harleco devices

FDA 510(k) Submission Details - K812591

510(k) Number K812591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1981
Decision Date September 24, 1981
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.

CKA Device Classification - Class 1, General Controls

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 117
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K812591.
TECHNICON RA-1000 SYSTEM ADD. ANALYT
K820394 · Technicon Instruments Corp. · Mar 1982
ALT (SGPT)
K813495 · Pointe Scientific, Inc., · Dec 1981
ALT-QUANTICHROM
K812926 · Abbott Laboratories · Nov 1981
ALT (UV) TEST
K810355 · Boehringer Mannheim Corp. · Feb 1981
DATA-ZYME LAT(GPT) PROCEDURE
K801857 · Data Medical Associates, Inc. · Sep 1980
REAGENT FOR DETERM. GLUTAMIC-PYRUVIC-
K800689 · Diagnostic Solutions, Inc. · May 1980