Cleared Traditional

K992997 - OSTEOMARK NTX POC

K992997 is the FDA 510(k) clearance for OSTEOMARK NTX POC by Metrika, Inc.. It is a Class 1 Chemistry device (product code JMM) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K992997 · Metrika, Inc. · Chemistry device
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Nov 1999
Decision
63d
Days
Class 1
Risk

K992997 is an FDA 510(k) clearance for the OSTEOMARK NTX POC. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Metrika, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 9, 1999 after a review of 63 days - a notably fast clearance 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: 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 Metrika, Inc. devices

Submission Details

510(k) Number K992997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1999
Decision Date November 09, 1999
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
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.

Regulatory Peers - JMM Column Chromatography & Color Development, Hydroxyproline

All 8
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K992997.
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · Roche Diagnostics Corp. · Jul 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
K983674 · Ortho-Clinical Diagnostics, Inc. · Jan 1999
IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · Diagnostic Products Corp. · May 1998
DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM
K972580 · Bayer Corp. · Sep 1997
IMMULITE PYRILINKS-D
K971312 · Diagnostic Products Corp. · May 1997
CIBA CORNING ACS
K963251 · Ciba Corning Diagnostics Corp. · Oct 1996