Cleared Traditional

K770870 - ULTRAZYME PLUS ALP

K770870 is the FDA 510(k) clearance for ULTRAZYME PLUS ALP by Harleco. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K770870 · Harleco · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1977
Decision
62d
Days
Class 2
Risk

K770870 is an FDA 510(k) clearance for the ULTRAZYME PLUS ALP. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1050 - 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 Harleco devices

Submission Details

510(k) Number K770870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1977
Decision Date July 14, 1977
Days to Decision 62 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
26d faster than avg
Panel avg: 88d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1050
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 - CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

All 84
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K770870.
ALKALINE PHOSPHATASE TEST
K771695 · Sclavo, Inc. · Oct 1977
MULTISTAT III ALKALINE PHOSPHATASE
K771470 · Instrumentation Laboratory CO · Sep 1977
DYNAZYME II ALKALINE PHOSPHATASE
K771085 · J.T. Baker Chemical Co. · Aug 1977
TECHNICON SMA & AAII SYSTEMS
K770406 · Boehringer Laboratories · Jun 1977
SIGMA PROCED #SC165
K760685 · Sigma Chemical Co. · Nov 1976
REAGENT, AMP BUFFER DIAGNOSTIC
K760397 · J.T. Baker Chemical Co. · Nov 1976