Cleared Traditional

K931986 - AMP ALKALINE PHOSPHATASE REAGENT KIT

K931986 is an FDA 510(k) clearance for AMP ALKALINE PHOSPHATASE REAGENT KIT, manufactured by Synermed, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K931986

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.

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 K931986.
ALKALINE PHOSPHATASE (ALKP) QVET
K942997 · Prisma Systems · Dec 1994
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