Cleared Traditional

K941313 - STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET

K941313 is an FDA 510(k) clearance for STANBIO ALKALINE PHOSPHATASE (LIQUICOLO..., manufactured by Stanbio Laboratory. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K941313 · Stanbio Laboratory · Chemistry device
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May 1994
Decision
60d
Days
Class 2
Risk

K941313 is an FDA 510(k) clearance for the STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K941313

510(k) Number K941313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1994
Decision Date May 17, 1994
Days to Decision 60 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
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K941313.
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · Medical Diagnostic Technologies, Inc. · Nov 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · Sigma Diagnostics, Inc. · Aug 1995
ALKALINE PHOSPHATASE (ALKP) QVET
K942997 · Prisma Systems · Dec 1994
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · Em Diagnostic Systems, Inc. · Dec 1993
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986 · Synermed, Inc. · Sep 1993
ALKALINE PHOSPHATASE KIT
K923507 · Randox Laboratories, Ltd. · Dec 1992