Cleared Traditional

K760024 - ULTRAZYME ALKALINE PHOSPHATASE

K760024 is the FDA 510(k) clearance for ULTRAZYME ALKALINE PHOSPHATASE by Harleco. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K760024 · Harleco · Chemistry device
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Aug 1976
Decision
73d
Days
Class 2
Risk

K760024 is an FDA 510(k) clearance for the ULTRAZYME ALKALINE PHOSPHATASE. 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 August 26, 1976 after a review of 73 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 K760024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1976
Decision Date August 26, 1976
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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 K760024.
SIGMA PROCED #SC165
K760685 · Sigma Chemical Co. · Nov 1976
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K760397 · J.T. Baker Chemical Co. · Nov 1976
REAGENT, MAGNESIUM CHLORIDE
K760398 · J.T. Baker Chemical Co. · Oct 1976
REAGENT, P-NITROPHENYL PHOSPHATE
K760399 · J.T. Baker Chemical Co. · Aug 1976