Cleared Traditional

K944080 - ALT QVET

K944080 is an FDA 510(k) clearance for ALT QVET, manufactured by Prisma Systems. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K944080 · Prisma Systems · Chemistry device
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Nov 1994
Decision
92d
Days
Class 1
Risk

K944080 is an FDA 510(k) clearance for the ALT QVET. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on November 22, 1994 after a review of 92 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Prisma Systems devices

FDA 510(k) Submission Details - K944080

510(k) Number K944080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1994
Decision Date November 22, 1994
Days to Decision 92 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 88d · This submission: 92d
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 102
Devices cleared under the same product code (CKA) and FDA review panel - the closest regulatory comparables to K944080.
ALANINE AMINOTRANSFERASE REAGENT SYSTEM
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HICHEM ALT REAGENT KIT
K951818 · Hi Chem, Inc. · May 1995
STANBIO ALT/GPT (LUQUI-UV) TEST SET
K941314 · Stanbio Laboratory · Jul 1994
LIQUID ALT(SGPT) REAGENT SET
K941287 · Pointe Scientific, Inc., · May 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · Em Diagnostic Systems, Inc. · Jan 1994