Cleared Traditional

K852441 - IN VITRO TESTS FOR PHOSPHATASE & BLOOD ...

K852441 is the FDA 510(k) clearance for IN VITRO TESTS FOR PHOSPHATASE & BLOOD ... by Clinical Data, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K852441 · Clinical Data, Inc. · Chemistry device
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Aug 1985
Decision
72d
Days
Class 2
Risk

K852441 is an FDA 510(k) clearance for the IN VITRO TESTS FOR PHOSPHATASE & BLOOD NITROGEN. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 72 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K852441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1985
Decision Date August 21, 1985
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
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 58
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K852441.
ALP (OPT) REAGENT
K862905 · Sigma Diagnostics, Inc. · Aug 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667 · Data Medical Associates, Inc. · May 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · Em Diagnostic Systems, Inc. · Feb 1986
VISION -FORMERLY PDA- ALKALINE PHOSPHATASE
K850110 · Abbott Laboratories · Jan 1985
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270 · Em Diagnostic Systems, Inc. · Sep 1984
ALKALINE PHOSPHATASE ASSAY KIT
K842243 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984