Cleared Traditional

K942997 - ALKALINE PHOSPHATASE (ALKP) QVET

K942997 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE (ALKP) QVET, manufactured by Prisma Systems. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K942997 · Prisma Systems · Chemistry device
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Dec 1994
Decision
189d
Days
Class 2
Risk

K942997 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE (ALKP) QVET. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 29, 1994 after a review of 189 days - an extended review 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: 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 - K942997

510(k) Number K942997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1994
Decision Date December 29, 1994
Days to Decision 189 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 88d · This submission: 189d
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 87
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K942997.
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · Sigma Diagnostics, Inc. · Feb 1996
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · Medical Diagnostic Technologies, Inc. · Nov 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · Sigma Diagnostics, Inc. · Aug 1995
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313 · Stanbio Laboratory · May 1994
EMDS ALKANINE PHOSPHATASE (ALP) TEST
K935182 · Em Diagnostic Systems, Inc. · Dec 1993
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986 · Synermed, Inc. · Sep 1993