Cleared Traditional

K910158 - AMYLASE

K910158 is an FDA 510(k) clearance for AMYLASE, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K910158 · Pointe Scientific, Inc., · Chemistry device
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Apr 1991
Decision
105d
Days
Class 2
Risk

K910158 is an FDA 510(k) clearance for the AMYLASE. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on April 30, 1991 after a review of 105 days - within the typical 510(k) review window.

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 Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K910158

510(k) Number K910158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date April 30, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFJ Device Classification - Class 2, Special Controls

Product Code JFJ Catalytic Methods, 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 - JFJ Catalytic Methods, Amylase

All 93
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K910158.
IL TEST(TM) AMLYLASE
K913744 · Instrumentation Laboratory CO · Feb 1992
AMYLASE REAGENT (PROCEDURE 577)
K913858 · Sigma Diagnostics, Inc. · Sep 1991
AMYLASE REAGENT
K912519 · Genzyme Corp. · Jul 1991
KINETIC AMYLASE DETERMINATION
K905651 · Biochemical Trade, Inc. · Jan 1991
ROCHE COBAS READY AMYLASE REAGENT
K903309 · Roche Diagnostic Systems, Inc. · Sep 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
K903332 · Em Diagnostic Systems, Inc. · Aug 1990