Cleared Traditional

K821882 - ULTRAZYME PLUS GPT

K821882 is the FDA 510(k) clearance for ULTRAZYME PLUS GPT by Harleco Diagnostics. It is a Class 1 Chemistry device (product code CKA) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K821882 · Harleco Diagnostics · Chemistry device
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Jul 1982
Decision
19d
Days
Class 1
Risk

K821882 is an FDA 510(k) clearance for the ULTRAZYME PLUS GPT. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Harleco Diagnostics (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982 after a review of 19 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 Diagnostics devices

Submission Details

510(k) Number K821882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1982
Decision Date July 14, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
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 99
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K821882.
ALT -LTS
K832639 · Electro-Nucleonics Laboratories, Inc. · Sep 1983
FLOW-PAC SGPT REAGENT
K830959 · Amresco, Inc. · May 1983
ALT ENZYME ASSAY KIT
K821946 · Travenol Laboratories, S.A. · Jul 1982
PYRIDOXAL-5-PHOSPHATE STRIPES
K821805 · Boehringer Mannheim Corp. · Jul 1982
LIQUID-STAT TM AST-UV LIQUID ENZUNE
K821048 · Beckman Instruments, Inc. · May 1982
RAICHEM GPT (ALT) REAGENT
K820525 · Reagents Applications, Inc. · Mar 1982