Cleared Traditional

AMYLASE (ETHYLIDENE PNGPG7) KIT (K953211) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953211 · Randox Laboratories, Ltd. · Chemistry device
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Jun 1996
Decision
347d
Days
Class 2
Risk

K953211 is an FDA 510(k) clearance for the AMYLASE (ETHYLIDENE PNGPG7) KIT. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on June 21, 1996 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1070 - 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. Elevated predicate reliance profile. 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K953211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date June 21, 1996
Days to Decision 347 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
259d slower than avg
Panel avg: 88d · This submission: 347d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, Amylase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1070
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 - CIJ Saccharogenic, Amylase

All 30
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K953211.
-AMYLASE EPS
K882225 · Boehringer Mannheim Corp. · Jan 1989
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · Roche Diagnostic Systems, Inc. · Oct 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · Instrumentation Laboratory CO · Oct 1987
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986
SYSTEMATE A AMYLASE HEM 67204
K843645 · Em Diagnostic Systems, Inc. · Sep 1984
ENZYMATIC AMYLASE REAGENT KIT
K760415 · Beckman Instruments, Inc. · Nov 1976