Cleared Traditional

K981373 - ALKPHASE-B ASSAY KIT

K981373 is an FDA 510(k) clearance for ALKPHASE-B ASSAY KIT, manufactured by Metra Biosystems, Inc.. The device is a Class 2 Chemistry device with product code CIN cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K981373 · Metra Biosystems, Inc. · Chemistry device
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May 1998
Decision
41d
Days
Class 2
Risk

K981373 is an FDA 510(k) clearance for the ALKPHASE-B ASSAY KIT. Classified as Electrophoretic Separation, Alkaline Phosphatase Isoenzymes (product code CIN), Class II - Special Controls.

Submitted by Metra Biosystems, Inc. (Mountain View, US). The FDA issued a Cleared decision on May 27, 1998 after a review of 41 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 Metra Biosystems, Inc. devices

FDA 510(k) Submission Details - K981373

510(k) Number K981373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1998
Decision Date May 27, 1998
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
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 21
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