Cleared Traditional

K812596 - ULTRA ZYME PLUS ALP #64962, 65029 & 30

K812596 is an FDA 510(k) clearance for ULTRA ZYME PLUS ALP #64962, manufactured by Harleco. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812596 · Harleco · Chemistry device
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Sep 1981
Decision
18d
Days
Class 2
Risk

K812596 is an FDA 510(k) clearance for the ULTRA ZYME PLUS ALP #64962, 65029 & 30. 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 September 29, 1981 after a review of 18 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

FDA 510(k) Submission Details - K812596

510(k) Number K812596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1981
Decision Date September 29, 1981
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJE Device Classification - Class 2, Special Controls

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 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K812596.
ULTRAZYME PLUS ALP
K821870 · Harleco Diagnostics · Jul 1982
ULTRAZYME PLUS ALP #64962,65029&65030
K821471 · Emd Chemicals, Inc. · Jun 1982
GILCHEM ALP REAGENT
K812912 · Gilford Diagnostics · Nov 1981
ALKALINE PHOSPHATASE
K812452 · Pointe Scientific, Inc., · Sep 1981
ALKALINE PHOSPH., LIQUID ENZY., KIN. KIT
K810082 · Bio-Analytics Laboratories, Inc. · Jan 1981
BECKMAN LIQUID STAT LIQUID/ALKALINE PHO
K802574 · Beckman Instruments, Inc. · Nov 1980