Cleared Traditional

K921578 - TITAN GEL ALKALINE PHOSPHATASE (HR)

K921578 is an FDA 510(k) clearance for TITAN GEL ALKALINE PHOSPHATASE (HR), manufactured by Helena Laboratories. The device is a Class 2 Chemistry device with 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

FDA 510(k) Submission Details - K921578

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.

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 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