Cleared Traditional

K984530 - DRX NTX OR

K984530 is the FDA 510(k) clearance for DRX NTX OR by Metrika, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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
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.

Device Classification

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 31
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K984530.
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp. · Jul 2002
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
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
REFLOTRON CREATININE TEST TABS
K903573 · Boehringer Mannheim Corp. · Sep 1990