Cleared Traditional

K934013 - RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT

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

K934013 · Isolab, Inc. · Chemistry device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K934013

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.

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 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