Cleared Traditional

VISION -FORMERLY PDA- ALKALINE PHOSPHATASE (K850110) - FDA 510(k) Clearance

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

K850110 · Abbott Laboratories · Chemistry device
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Jan 1985
Decision
15d
Days
Class 2
Risk

K850110 is an FDA 510(k) clearance for the VISION -FORMERLY PDA- ALKALINE PHOSPHATASE. Classified as Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes (product code CJE), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on January 29, 1985 after a review of 15 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 Abbott Laboratories devices

Submission Details

510(k) Number K850110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1985
Decision Date January 29, 1985
Days to Decision 15 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
73d faster than avg
Panel avg: 88d · This submission: 15d
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 41
Devices cleared under the same product code (CJE) and FDA review panel - the closest regulatory comparables to K850110.
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
K873681 · Em Diagnostic Systems, Inc. · Sep 1987
ALP (OPT) REAGENT
K862905 · Sigma Diagnostics, Inc. · Aug 1986
EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT
K860134 · Em Diagnostic Systems, Inc. · Feb 1986
SYSTEMATE ALKALINE PHOSPHATASE-67203
K843270 · Em Diagnostic Systems, Inc. · Sep 1984
SIGMA PROCED. 245 ALKALINE PHOSPHATASE
K841918 · Sigma Diagnostics, Inc. · Jun 1984
PARAMAX ALKALINE PHOSPHATASE REAGENT-
K831480 · American Dade · Jun 1983