Cleared Traditional

AMYLASE (KINETIC) REAGENT SET (K915704) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915704 · Tech Intl. Co. · Chemistry device
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Jun 1996
Decision
1675d
Days
Class 2
Risk

K915704 is an FDA 510(k) clearance for the AMYLASE (KINETIC) REAGENT SET. Classified as Nitrosalicylate Reduction, Amylase (product code CJD), Class II - Special Controls.

Submitted by Tech Intl. Co. (Placentia, US). The FDA issued a Cleared decision on June 28, 1996 after a review of 1675 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Tech Intl. Co. devices

Submission Details

510(k) Number K915704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1991
Decision Date June 28, 1996
Days to Decision 1675 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
1587d slower than avg
Panel avg: 88d · This submission: 1675d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJD Nitrosalicylate Reduction, 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.