Cleared Traditional

K935182 - EMDS ALKANINE PHOSPHATASE (ALP) TEST

K935182 is the FDA 510(k) clearance for EMDS ALKANINE PHOSPHATASE (ALP) TEST by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K935182 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1993
Decision
43d
Days
Class 2
Risk

K935182 is an FDA 510(k) clearance for the EMDS ALKANINE PHOSPHATASE (ALP) TEST. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 9, 1993 after a review of 43 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K935182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1993
Decision Date December 09, 1993
Days to Decision 43 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
45d faster than avg
Panel avg: 88d · This submission: 43d
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 83
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K935182.
ALKALINE PHOSPHATASE REAGENT SYSTEM
K952746 · Medical Diagnostic Technologies, Inc. · Nov 1995
ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247
K951584 · Sigma Diagnostics, Inc. · Aug 1995
STANBIO ALKALINE PHOSPHATASE (LIQUICOLOR) TEST SET
K941313 · Stanbio Laboratory · May 1994
AMP ALKALINE PHOSPHATASE REAGENT KIT
K931986 · Synermed, Inc. · Sep 1993
ALKALINE PHOSPHATASE KIT
K923507 · Randox Laboratories, Ltd. · Dec 1992
OLYMPUS ALKALINE PHOSPHATASE REAGENT
K925156 · Olympus Corp. · Nov 1992