Cleared Special

K991797 - IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5

K991797 is an FDA 510(k) clearance for IMMULITE TURBO CK-MB, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code JHX cleared through the Special 510(k) pathway after a 14-day FDA review.

K991797 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
14d
Days
Class 2
Risk

K991797 is an FDA 510(k) clearance for the IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 9, 1999 after a review of 14 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.

FDA 510(k) Submission Details - K991797

510(k) Number K991797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 1999
Decision Date June 09, 1999
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

JHX Device Classification - Class 2, Special Controls

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 45
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K991797.
ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER
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ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306
K994439 · Beckman Coulter, Inc. · Jan 2000
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068 · Ortho-Clinical Diagnostics · Oct 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
CREATINE KINASE REAGENT
K980012 · Ac Biochemicals, Inc. · Feb 1998
K991797 · IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
Download PDF FDA Summary Diagnostic Products C…