Cleared Special

K991796 - IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5

K991796 is an FDA 510(k) clearance for IMMULITE TURBO MYOGLOBIN, manufactured by Diagnostic Products Corp.. The device is a Class 2 Chemistry device with product code DDR cleared through the Special 510(k) pathway after a 14-day FDA review.

K991796 · 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

K991796 is an FDA 510(k) clearance for the IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5. Classified as Myoglobin, Antigen, Antiserum, Control (product code DDR), 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 866.5680 - 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 - K991796

510(k) Number K991796 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.

DDR Device Classification - Class 2, Special Controls

Product Code DDR Myoglobin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5680
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 - DDR Myoglobin, Antigen, Antiserum, Control

All 44
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K991796.
RANDOX MYOGLOBIN
K010700 · Randox Laboratories, Ltd. · May 2001
ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316
K000196 · Beckman Coulter, Inc. · Feb 2000
K-ASSAY MYOGLOBIN ASSAY, K-ASSAY MYOGLOBIN CALIBRATOR
K992976 · Kamiya Biomedical Co. · Nov 1999
MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
K991277 · Diagnostic Products Corp. · Apr 1999
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
K984145 · Olympus Diagnostica GmbH · Dec 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · Dade Behring, Inc. · Dec 1998
K991796 · IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
Download PDF FDA Summary Diagnostic Products C…