Cleared Traditional

COBAS REAGENT FOR ALT (GPT) (K801119) - FDA 510(k) Clearance

Class I Chemistry device.

K801119 · Roche Analytical Instruments, Inc. · Chemistry device
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Jun 1980
Decision
28d
Days
Class 1
Risk

K801119 is an FDA 510(k) clearance for the COBAS REAGENT FOR ALT (GPT). Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Roche Analytical Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 28 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 Roche Analytical Instruments, Inc. devices

Submission Details

510(k) Number K801119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1980
Decision Date June 09, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 43
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K801119.
TECHNICON RA-1000 SYSTEM ADD. ANALYT
K820394 · Technicon Instruments Corp. · Mar 1982
ALT-QUANTICHROM
K812926 · Abbott Laboratories · Nov 1981
ALT (UV) TEST
K810355 · Boehringer Mannheim Corp. · Feb 1981
SINGLE VIAL 10 SGPT-TRIS
K780636 · Boehringer Mannheim Corp. · May 1978
STAC SYSTEM
K780373 · Technicon Instruments Corp. · Apr 1978
ALANINE TRANSAMINASE
K780040 · Beckman Instruments, Inc. · Jan 1978