Cleared Traditional

K830118 - ALKALINE PHOSPHATES ISOENZYME SUBSTRATE

K830118 is an FDA 510(k) clearance for ALKALINE PHOSPHATES ISOENZYME SUBSTRATE, manufactured by Corning Medical & Scientific. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K830118 · Corning Medical & Scientific · Chemistry device
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Feb 1983
Decision
45d
Days
Class 2
Risk

K830118 is an FDA 510(k) clearance for the ALKALINE PHOSPHATES ISOENZYME SUBSTRATE. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on February 25, 1983 after a review of 45 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 Corning Medical & Scientific devices

FDA 510(k) Submission Details - K830118

510(k) Number K830118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1983
Decision Date February 25, 1983
Days to Decision 45 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
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIN Device Classification - Class 2, Special Controls

Product Code CIN Electrophoretic Separation, Alkaline Phosphatase 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 - CIN Electrophoretic Separation, Alkaline Phosphatase Isoenzymes

All 22
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K830118.
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341 · Helena Laboratories · Feb 1989
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · Ciba Corning Diagnostics Corp. · Feb 1989
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
K870890 · Helena Laboratories · Jun 1987
ALKALINE PHOSPHATASE MARKER
K792548 · Electrophoresis Corp. of America · Jan 1980
ALKALINE PHOSPHATASE ISOENZY. SUB. SET
K771620 · Pfizer, Inc. · Sep 1977
AP ISOTROL, #A 0140
K771225 · Sigma Chemical Co. · Aug 1977