Cleared Traditional

K915710 - AMYLASE (COLORIMETRIC) REAGENT SET

K915710 is an FDA 510(k) clearance for AMYLASE (COLORIMETRIC) REAGENT SET, manufactured by Tech Intl. Co.. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K915710 · Tech Intl. Co. · Chemistry device
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Jan 1992
Decision
62d
Days
Class 2
Risk

K915710 is an FDA 510(k) clearance for the AMYLASE (COLORIMETRIC) REAGENT SET. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Tech Intl. Co. (Rochester Hills, US). The FDA issued a Cleared decision on January 30, 1992 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tech Intl. Co. devices

FDA 510(k) Submission Details - K915710

510(k) Number K915710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date January 30, 1992
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
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 94
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K915710.
AMYLASE REAGENT
K921057 · Genzyme Corp. · Mar 1992
ABBOTT QUICKSTART AMYLASE, #5AXX
K920583 · Em Diagnostic Systems, Inc. · Mar 1992
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
AMYLASE
K910158 · Pointe Scientific, Inc., · Apr 1991