Cleared Traditional

K860245 - ENZYMATIC ALPHA-AMYLASE REAGENT KIT

K860245 is the FDA 510(k) clearance for ENZYMATIC ALPHA-AMYLASE REAGENT KIT by Bio-Analytics Laboratories, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K860245 · Bio-Analytics Laboratories, Inc. · Chemistry device
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Mar 1986
Decision
49d
Days
Class 2
Risk

K860245 is an FDA 510(k) clearance for the ENZYMATIC ALPHA-AMYLASE REAGENT KIT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Bio-Analytics Laboratories, Inc. (Palm City, US). The FDA issued a Cleared decision on March 14, 1986 after a review of 49 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 Bio-Analytics Laboratories, Inc. devices

Submission Details

510(k) Number K860245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1986
Decision Date March 14, 1986
Days to Decision 49 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 88d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 74
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K860245.
AMYLASE REAGENT CATALOGUE NOS. 85108 AND 85109
K861718 · Reagents Applications, Inc. · May 1986
ALPHA-AMYLASE TEST
K860665 · Sclavo, Inc. · Apr 1986
EASY-TEST AMLASE (AMYL), #67521/93
K860918 · Em Diagnostic Systems, Inc. · Apr 1986
AMY REAGENT
K852001 · Alpkem Corp. · Jun 1985
AMYLASE PRODUCTS
K850798 · Data Medical Associates, Inc. · Mar 1985
AMYLASE
K832889 · Pointe Scientific, Inc., · Nov 1983