Cleared Traditional

K931986 - AMP ALKALINE PHOSPHATASE REAGENT KIT

K931986 is the FDA 510(k) clearance for AMP ALKALINE PHOSPHATASE REAGENT KIT by Synermed, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K931986 · Synermed, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1993
Decision
139d
Days
Class 2
Risk

K931986 is an FDA 510(k) clearance for the AMP ALKALINE PHOSPHATASE REAGENT KIT. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Synermed, Inc. (Quebec, Canada, CA). The FDA issued a Cleared decision on September 8, 1993 after a review of 139 days - within the typical 510(k) review window.

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 Synermed, Inc. devices

Submission Details

510(k) Number K931986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1993
Decision Date September 08, 1993
Days to Decision 139 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
51d slower than avg
Panel avg: 88d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 85
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K931986.
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
ALKALINE PHOSPHATASE KIT
K923507 · Randox Laboratories, Ltd. · Dec 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K925156 · Olympus Corp. · Nov 1992
EMDS ALKALINE PHOSPHATASE (ALP) TEST
K924574 · Em Diagnostic Systems, Inc. · Nov 1992