Cleared Traditional

K951494 - AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)

K951494 is an FDA 510(k) clearance for AMYLASE TEST ITEM 97381/94 (R1, manufactured by Emd Chemicals, Inc.. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K951494

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.

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 K951494.
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OLYMPUS AMYLASE REAGENT
K931301 · Olympus Corp. · Oct 1993