Cleared Traditional

K981364 - PYRILINKS-D ASSAY KIT

K981364 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 120-day FDA review.

K981364 · Metra Biosystems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
120d
Days
Class 1
Risk

K981364 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. (Mountain View, US). The FDA issued a Cleared decision on August 13, 1998 after a review of 120 days - within the typical 510(k) review window.

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 - K981364

510(k) Number K981364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1998
Decision Date August 13, 1998
Days to Decision 120 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
32d slower than avg
Panel avg: 88d · This submission: 120d
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.

Regulatory Peers - JMM Column Chromatography & Color Development, Hydroxyproline

All 15
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K981364.
OSTEOMARK NTX SERUM EIA
K983457 · Ostex Intl., Inc. · Feb 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
K983674 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
CROSSLAPS ELISA
K972788 · Devices and Diagnostics Consulting Group · Dec 1998
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · Diagnostic Products Corp. · May 1998
OSTEOMARK
K980518 · Ostex Intl., Inc. · Mar 1998
PYRILINKS-D ASSAY KIT
K974260 · Metra Biosystems, Inc. · Jan 1998