Cleared Traditional

PYRILINKS POLYCLONAL ASSAY KIT (K952026) - FDA 510(k) Clearance

Class I Chemistry device.

K952026 · Metra Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1995
Decision
186d
Days
Class 1
Risk

K952026 is an FDA 510(k) clearance for the PYRILINKS POLYCLONAL 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 November 3, 1995 after a review of 186 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

Submission Details

510(k) Number K952026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1995
Decision Date November 03, 1995
Days to Decision 186 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
98d slower than avg
Panel avg: 88d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.