Cleared Traditional

K941314 - STANBIO ALT/GPT (LUQUI-UV) TEST SET

K941314 is an FDA 510(k) clearance for STANBIO ALT/GPT (LUQUI-UV) TEST SET, manufactured by Stanbio Laboratory. The device is a Class 1 Chemistry device with product code CKA cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K941314 · Stanbio Laboratory · Chemistry device
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Jul 1994
Decision
124d
Days
Class 1
Risk

K941314 is an FDA 510(k) clearance for the STANBIO ALT/GPT (LUQUI-UV) TEST SET. Classified as Nadh Oxidation/nad Reduction, Alt/sgpt (product code CKA), Class I - General Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on July 20, 1994 after a review of 124 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K941314

510(k) Number K941314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date July 20, 1994
Days to Decision 124 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 88d · This submission: 124d
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 K941314.
PARAMAX ALANINE AMINOTRANSFERASE (GPT) REAGENT
K951332 · Dade Intl., Inc. · Jun 1995
HICHEM ALT REAGENT KIT
K951818 · Hi Chem, Inc. · May 1995
ALT QVET
K944080 · Prisma Systems · Nov 1994
LIQUID ALT(SGPT) REAGENT SET
K941287 · Pointe Scientific, Inc., · May 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
K935180 · Em Diagnostic Systems, Inc. · Jan 1994
HEMOCARD HEMOGLOBIN E
K930070 · Isolab, Inc. · Apr 1993