Cleared Traditional

K984530 - DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE

K984530 is an FDA 510(k) clearance for DRX NTX OR, manufactured by Metrika, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K984530 · Metrika, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
232d
Days
Class 2
Risk

K984530 is an FDA 510(k) clearance for the DRX NTX OR, OSTEOMARK NTX DIRECT RESPONSE. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Metrika, Inc. (Los Angeles, US). The FDA issued a Cleared decision on August 10, 1999 after a review of 232 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 Metrika, Inc. devices

FDA 510(k) Submission Details - K984530

510(k) Number K984530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1998
Decision Date August 10, 1999
Days to Decision 232 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 88d · This submission: 232d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JFY Enzymatic Method, Creatinine

All 41
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K984530.
BIOSCANNER CREATININE TEST STRIPS
K010456 · Polymer Technology Systems, Inc. · Jun 2001
CREATININE PLUS
K003261 · Roche Diagnostics Corp. · Nov 2000
VITROS CHEMISTRY PRODUCTS CREA SLIDE, VIRTROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K001310 · Ortho-Clinical Diagnostics, Inc. · May 2000
CARESIDE CREATININE
K980043 · Exigent Diagnostics, Inc. · Mar 1998
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
K912807 · Em Diagnostic Systems, Inc. · Oct 1991
REFLOTRON CREATININE TEST TABS
K913105 · Boehringer Mannheim Corp. · Aug 1991