Cleared Traditional

K983674 - VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS

K983674 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX C..., manufactured by Ortho-Clinical Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K983674 · Ortho-Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
101d
Days
Class 1
Risk

K983674 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONT.... Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 29, 1999 after a review of 101 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 Ortho-Clinical Diagnostics, Inc. devices

FDA 510(k) Submission Details - K983674

510(k) Number K983674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1998
Decision Date January 29, 1999
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K983674.
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PYRILINKS-D ASSAY KIT
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IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5
K980833 · Diagnostic Products Corp. · May 1998