Cleared Traditional

K934013 - RESOLVE SYSTEMS ALKALINE PHOSPHATASE TE...

K934013 is the FDA 510(k) clearance for RESOLVE SYSTEMS ALKALINE PHOSPHATASE TE... by Isolab, Inc.. It is a Class 2 Chemistry device (product code CIN) cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K934013 · Isolab, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
251d
Days
Class 2
Risk

K934013 is an FDA 510(k) clearance for the RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Isolab, Inc. (Akron, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 251 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Isolab, Inc. devices

Submission Details

510(k) Number K934013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1993
Decision Date April 26, 1994
Days to Decision 251 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
163d slower than avg
Panel avg: 88d · This submission: 251d
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 17
Devices cleared under the same product code (CIN) and FDA review panel - the closest regulatory comparables to K934013.
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · Hybritech, Inc. · Sep 1997
OPUS BONE ALP
K964764 · Behring Diagnostics, Inc. · Jan 1997
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573 · Hybritech, Inc. · Aug 1996
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · Hybritech, Inc. · Jan 1994
TITAN GEL ALKALINE PHOSPHATASE (HR)
K921578 · Helena Laboratories · Sep 1992
REP ALP-15, 8, & 4 KITS
K912603 · Helena Laboratories · Jul 1991