Cleared Traditional

K870746 - STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715

K870746 is an FDA 510(k) clearance for STANBIO ALPHA-AMYLASE TEST SET, manufactured by Stanbio Laboratory. The device is a Class 2 Chemistry device with product code JFJ cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K870746 · Stanbio Laboratory · Chemistry device
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Jun 1987
Decision
96d
Days
Class 2
Risk

K870746 is an FDA 510(k) clearance for the STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on June 1, 1987 after a review of 96 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 Stanbio Laboratory devices

FDA 510(k) Submission Details - K870746

510(k) Number K870746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1987
Decision Date June 01, 1987
Days to Decision 96 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
8d slower than avg
Panel avg: 88d · This submission: 96d
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 92
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K870746.
A-GENT LIQUID AMYLASE
K873944 · Abbott Laboratories · Nov 1987
BNP-AMYLASE TEST
K873133 · Sclavo, Inc. · Oct 1987
AMYLASE TEST KIT
K872023 · Ciba Corning Diagnostics Corp. · Aug 1987
RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C)
K871269 · Technicon Instruments Corp. · Apr 1987
AMYLASE COLORIMETRIC PROCEDURE
K864825 · Data Medical Associates, Inc. · Feb 1987
PSI AMYLASE REAGENT
K864464 · Pointe Scientific, Inc., · Jan 1987