Cleared Traditional

K880307 - ALKALINE PHOSPHATASE REAGENT SET

K880307 is an FDA 510(k) clearance for ALKALINE PHOSPHATASE REAGENT SET, manufactured by Tech-Neal Scientific, Inc.. The device is a Class 2 Chemistry device with product code CJE cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K880307 · Tech-Neal Scientific, Inc. · Chemistry device
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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

FDA 510(k) Submission Details - K880307

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
Combination Product No
PCCP Authorized No
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.

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 115
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K880307.
BIOTROL ALKALINE PHOSPHATASE
K881742 · Biotrol, USA, Inc. · Jul 1988
RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.
K880795 · Trace America, Inc. · Apr 1988
ALKALINE PHOSPHATASE REAGENT, DEA BUFF
K880796 · Trace America, Inc. · Apr 1988
ALKALINE PHOSPHATASE CAT. # 306-22, 306-23
K875210 · Diagnostic Chemicals, Ltd. (Usa) · Feb 1988
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
K873635 · Em Diagnostic Systems, Inc. · Oct 1987
MULTICHEM ALKALINE PHOSPHATASE (S0903)
K873761 · Simmler, Inc. · Oct 1987