Cleared Traditional

K861269 - RAICHEM AMYLASE REAGENT

K861269 is the FDA 510(k) clearance for RAICHEM AMYLASE REAGENT by Reagents Applications, Inc.. It is a Class 2 Chemistry device (product code JFJ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K861269 · Reagents Applications, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
55d
Days
Class 2
Risk

K861269 is an FDA 510(k) clearance for the RAICHEM AMYLASE REAGENT. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on May 29, 1986 after a review of 55 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K861269 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1986
Decision Date May 29, 1986
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 72
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K861269.
TDX(R) AMYLASE II
K863622 · Abbott Laboratories · Oct 1986
AMYLASE SR LIQUID STABLE REAGENT SET
K862733 · Medical Analysis Systems, Inc. · Sep 1986
AMYLASE PROCEDURE
K863588 · Data Medical Associates, Inc. · Sep 1986
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