Cleared Traditional

K952320 - PYRILINKS-D ASSAY KIT

K952320 is an FDA 510(k) clearance for PYRILINKS-D ASSAY KIT, manufactured by Metra Biosystems, Inc.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K952320 · Metra Biosystems, Inc. · Chemistry device
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Dec 1995
Decision
225d
Days
Class 1
Risk

K952320 is an FDA 510(k) clearance for the PYRILINKS-D ASSAY KIT. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Metra Biosystems, Inc. (Laurel, US). The FDA issued a Cleared decision on December 29, 1995 after a review of 225 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1400 - 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 Metra Biosystems, Inc. devices

FDA 510(k) Submission Details - K952320

510(k) Number K952320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date December 29, 1995
Days to Decision 225 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 88d · This submission: 225d
Pathway characteristics
Predicate-based equivalence.

JMM Device Classification - Class 1, General Controls

Product Code JMM Column Chromatography & Color Development, Hydroxyproline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.