Cleared Special

K993068 - VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB ...

Also marketed or referenced as:
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS

K993068 is the FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB ... by Ortho-Clinical Diagnostics. It is a Class 2 Chemistry device (product code JHX) cleared through the Special 510(k) pathway after a 21-day FDA review.

K993068 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
21d
Days
Class 2
Risk

K993068 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on October 4, 1999 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ortho-Clinical Diagnostics devices

Submission Details

510(k) Number K993068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1999
Decision Date October 04, 1999
Days to Decision 21 days
Submission Type Special
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
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JHX Fluorometric Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 29
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K993068.
IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS)
K004002 · Diagnostic Products Corp. · Feb 2001
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
K000716 · Beckman Coulter, Inc. · Mar 2000
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
K994439 · Beckman Coulter, Inc. · Jan 2000
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · Diagnostic Products Corp. · Jun 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · Dade Behring, Inc. · Jan 1999
STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK
K981099 · Dade Behring, Inc. · May 1998