Cleared Traditional

K862256 - ALKALINE PHOSPHATASE (PNPP RATE) REAGEN...

K862256 is the FDA 510(k) clearance for ALKALINE PHOSPHATASE (PNPP RATE) REAGEN... by Sterling Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CJE) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K862256 · Sterling Diagnostics, Inc. · Chemistry device
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Jul 1986
Decision
18d
Days
Class 2
Risk

K862256 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on July 1, 1986 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K862256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 1986
Decision Date July 01, 1986
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.

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 84
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K862256.
ALKALINE PHOSPHATASE TEST
K862498 · King Diagnostics, Inc. · Sep 1986
ALP S.C.E.
K863051 · J. D. Assoc. · Sep 1986
ALP (OPT) REAGENT
K862905 · Sigma Diagnostics, Inc. · Aug 1986
ALKALINE PHOSPHATASE PROCEDURE
K861667 · Data Medical Associates, Inc. · May 1986
AP REAGENT CARTRIDGE
K861284 · Hi Chem, Inc. · Apr 1986
ALP (ALKALINE PHOSPHATASE) REAGENT
K860715 · Trace Scientific , Ltd. · Apr 1986