Cleared Traditional

ALKALINE PHOSPHATASE REAGENT SET (K880307) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880307 · Tech-Neal Scientific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
50d
Days
Class 2
Risk

K880307 is an FDA 510(k) clearance for the ALKALINE PHOSPHATASE REAGENT SET. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Tech-Neal Scientific, Inc. (Westmont, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 50 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 Tech-Neal Scientific, Inc. devices

Submission Details

510(k) Number K880307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1988
Decision Date March 15, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 88d · This submission: 50d
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 32
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K880307.
SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402
K895250 · Em Diagnostic Systems, Inc. · Oct 1989
ABBOTT CLINICAL CHEMISTRY REAGENT ALP
K890521 · Abbott Laboratories · Mar 1989
ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651
K884549 · Em Diagnostic Systems, Inc. · Nov 1988
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · Em Diagnostic Systems, Inc. · Oct 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · Em Diagnostic Systems, Inc. · Sep 1987
ALP (OPT) REAGENT
K862905 · Sigma Diagnostics, Inc. · Aug 1986