Cleared Traditional

K921578 - TITAN GEL ALKALINE PHOSPHATASE (HR)

K921578 is the FDA 510(k) clearance for TITAN GEL ALKALINE PHOSPHATASE (HR) by Helena Laboratories. It is a Class 2 Chemistry device (product code CIN) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K921578 · Helena Laboratories · Chemistry device
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Sep 1992
Decision
174d
Days
Class 2
Risk

K921578 is an FDA 510(k) clearance for the TITAN GEL ALKALINE PHOSPHATASE (HR). Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on September 23, 1992 after a review of 174 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 Helena Laboratories devices

Submission Details

510(k) Number K921578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1992
Decision Date September 23, 1992
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
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 K921578.
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K961573 · Hybritech, Inc. · Aug 1996
RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT
K934013 · Isolab, Inc. · Apr 1994
TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY
K930810 · Hybritech, Inc. · Jan 1994
REP ALP-15, 8, & 4 KITS
K912603 · Helena Laboratories · Jul 1991
ALKALINE PHOSPHATASE ISOENZYME REAGENTS
K890269 · Beckman Instruments, Inc. · Mar 1989
TITAN GEL ALKALINE PHOSPHATASE (HR)
K885341 · Helena Laboratories · Feb 1989