Cleared Traditional

K810144 - ALK-PHOS BIOPAK GEL

K810144 is the FDA 510(k) clearance for ALK-PHOS BIOPAK GEL by Bioware Products. It is a Class 2 Chemistry device (product code CIN) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K810144 · Bioware Products · Chemistry device
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Feb 1981
Decision
12d
Days
Class 2
Risk

K810144 is an FDA 510(k) clearance for the ALK-PHOS BIOPAK GEL. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Bioware Products (Mchenry, US). The FDA issued a Cleared decision on February 2, 1981 after a review of 12 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 Bioware Products devices

Submission Details

510(k) Number K810144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1981
Decision Date February 02, 1981
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 20
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K810144.
ALKALINE PHOSPHATASE ISOENZYME SYSTEM
K885024 · Ciba Corning Diagnostics Corp. · Feb 1989
ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT
K870890 · Helena Laboratories · Jun 1987
ALKALINE PHOSPHATES ISOENZYME SUBSTRATE
K830118 · Corning Medical & Scientific · Feb 1983
ALKALINE PHOSPHATASE ISOENZY. SUB. SET
K771620 · Pfizer, Inc. · Sep 1977
AP ISOTROL, #A 0140
K771225 · Sigma Chemical Co. · Aug 1977
PROCEDURE NO. 710-EP FOR ALK.PHOS.
K760862 · Sigma Chemical Co. · Nov 1976