Cleared Traditional

K964914 - ALKALINE PHOSPHATASE

K964914 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE, manufactured by Derma Media Lab., Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K964914 · Derma Media Lab., Inc. · Chemistry device
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Feb 1997
Decision
57d
Days
Class 2
Risk

K964914 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 57 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 Derma Media Lab., Inc. devices

FDA 510(k) Submission Details - K964914

510(k) Number K964914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date February 04, 1997
Days to Decision 57 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 88d · This submission: 57d
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 111
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K964914.
ALKALINE PHOSPHATASE-SL ASSAY CATALOGUE NUMBER 309-10, 309-30
K980316 · Diagnostic Chemicals , Ltd. · Feb 1998
LIQUID ALKALINE PHOSHATASE REAGENT SET
K973588 · Pointe Scientific, Inc., · Oct 1997
ALP REAGENT SET
K971463 · Carolina Liquid Chemistries Corp. · May 1997
ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245
K954840 · Sigma Diagnostics, Inc. · Feb 1996
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · Medical Diagnostic Technologies, Inc. · Nov 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · Sigma Diagnostics, Inc. · Aug 1995