Cleared Traditional

K953211 - AMYLASE (ETHYLIDENE PNGPG7) KIT

K953211 is an FDA 510(k) clearance for AMYLASE (ETHYLIDENE PNGPG7) KIT, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Chemistry device with product code CIJ cleared through the Traditional 510(k) pathway after a 347-day FDA review.

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

FDA 510(k) Submission Details - K953211

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
Combination Product No
PCCP Authorized No
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.

CIJ Device Classification - Class 2, Special Controls

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-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
K023396 · Pointe Scientific, Inc., · Dec 2002
ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM
K991817 · Bayer Corp. · Jul 1999
AMYLASE
K980013 · Ac Biochemicals, Inc. · Feb 1998
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
K951494 · Emd Chemicals, Inc. · Dec 1995
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · Pointe Scientific, Inc., · Aug 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · Data Medical Associates, Inc. · Mar 1994