Cleared Traditional

MULTISTAT III, AMYLASE TEST (K771622) - FDA 510(k) Clearance

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

K771622 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1977
Decision
19d
Days
Class 2
Risk

K771622 is an FDA 510(k) clearance for the MULTISTAT III, AMYLASE TEST. Classified as Catalytic Methods, Amylase (product code JFJ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on September 13, 1977 after a review of 19 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K771622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1977
Decision Date September 13, 1977
Days to Decision 19 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 88d · This submission: 19d
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 98
Devices cleared under the same product code (JFJ) and FDA review panel - the closest regulatory comparables to K771622.
Amylase2
K210633 · Abbott Ireland Diagnostics Division · May 2022
Atellica CH Amylase_2 (AMY_2)
K191454 · Siemens Healthcare Diagnostics, Inc. · Jul 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
K182474 · Biosystems S.A. · May 2019
AMY
K981653 · Abbott Laboratories · Aug 1998
AMY
K981216 · Abbott Laboratories · Jun 1998
ABBOTT SPECTRUM AMYLASE REAGENT
K891241 · Abbott Laboratories · Aug 1989