Cleared Traditional

K991762 - ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02

K991762 is an FDA 510(k) clearance for ALKALINE PHOPHATASE (ALP), manufactured by A.P. Total Care, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K991762 · A.P. Total Care, Inc. · Chemistry device
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Sep 1999
Decision
101d
Days
Class 2
Risk

K991762 is an FDA 510(k) clearance for the ALKALINE PHOPHATASE (ALP), PRODUCT NO'S 118-01, 118-02. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by A.P. Total Care, Inc. (Bridgeport, US). The FDA issued a Cleared decision on September 2, 1999 after a review of 101 days - within the typical 510(k) review window.

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: 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 A.P. Total Care, Inc. devices

FDA 510(k) Submission Details - K991762

510(k) Number K991762 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date September 02, 1999
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K991762.
ALKALINE PHOSPHATASE LIQUID REAGENT
K011599 · Jas Diagnostics, Inc. · Jul 2001
ALKALINE PHOSPHATASE-SL ASSAY, MODELS 328-17 AND 328-30
K003093 · Diagnostic Chemicals , Ltd. · Nov 2000
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H
K000067 · Teco Diagnostics · Jan 2000
CARESIDE ALKALINE PHOSPHATASE
K990024 · Careside, Inc. · Jan 1999
ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE
K981897 · Roche Diagnostic Systems, Inc. · Aug 1998
ALKP
K981806 · Abbott Laboratories · Jun 1998