Cleared Traditional

ULTRAZYME AMYLASE (K760026) - FDA 510(k) Clearance

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

K760026 · Harleco · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1976
Decision
99d
Days
Class 2
Risk

K760026 is an FDA 510(k) clearance for the ULTRAZYME AMYLASE. Classified as Saccharogenic, Amylase (product code CIJ), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 21, 1976 after a review of 99 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 Harleco devices

Submission Details

510(k) Number K760026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1976
Decision Date September 21, 1976
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 88d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIJ Saccharogenic, 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 - CIJ Saccharogenic, Amylase

All 30
Devices cleared under the same product code (CIJ) and FDA review panel - the closest regulatory comparables to K760026.
-AMYLASE EPS
K882225 · Boehringer Mannheim Corp. · Jan 1989
ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL
K873250 · Roche Diagnostic Systems, Inc. · Oct 1987
IL 35260, IL TEST AMYLASE REAGENT
K873572 · Instrumentation Laboratory CO · Oct 1987
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
K860935 · Em Diagnostic Systems, Inc. · May 1986
SYSTEMATE A AMYLASE HEM 67204
K843645 · Em Diagnostic Systems, Inc. · Sep 1984
ENZYMATIC AMYLASE REAGENT KIT
K760415 · Beckman Instruments, Inc. · Nov 1976