Cleared Traditional

K951494 - AMYLASE TEST ITEM 97381/94 (R1

K951494 is the FDA 510(k) clearance for AMYLASE TEST ITEM 97381/94 (R1 by Emd Chemicals, Inc.. It is a Class 2 Chemistry device (product code CIJ) cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K951494 · Emd Chemicals, Inc. · Chemistry device
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Dec 1995
Decision
255d
Days
Class 2
Risk

K951494 is an FDA 510(k) clearance for the AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR). Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 11, 1995 after a review of 255 days - an extended review cycle.

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. 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K951494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1995
Decision Date December 11, 1995
Days to Decision 255 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
167d slower than avg
Panel avg: 88d · This submission: 255d
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 28
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K951494.
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 (ETHYLIDENE PNGPG7) KIT
K953211 · Randox Laboratories, Ltd. · Jun 1996
LIQUID AMYLASE (CNPG3) REAGENT SET
K940735 · Pointe Scientific, Inc., · Aug 1994
DMA AMYLASE (DEMAND) PROCEDURE
K940010 · Data Medical Associates, Inc. · Mar 1994
OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 1993