Cleared Traditional

K011052 - OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE

K011052 is an FDA 510(k) clearance for OSTEOMARK NTX POINT OF CARE PRESCRIPTIO..., manufactured by Ostex Intl., Inc.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K011052 · Ostex Intl., Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
115d
Days
Class 1
Risk

K011052 is an FDA 510(k) clearance for the OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE. Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Ostex Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on July 30, 2001 after a review of 115 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 Ostex Intl., Inc. devices

FDA 510(k) Submission Details - K011052

510(k) Number K011052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date July 30, 2001
Days to Decision 115 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
27d slower than avg
Panel avg: 88d · This submission: 115d
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 16
Devices cleared under the same product code (JMM) and FDA review panel - the closest regulatory comparables to K011052.
ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY
K993706 · Roche Diagnostics Corp. · Jul 2000
OSTEOMARK NTX POC
K992997 · Metrika, Inc. · Nov 1999
SERUM CROSSLAPS ONE STEP ELISA
K990843 · Osteometer Biotech A/S · Jul 1999
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