Cleared Special

K991277 - MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5

K991277 is an FDA 510(k) clearance for MODIFICATION TO IMMULITE 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 13-day FDA review.

K991277 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 1999
Decision
13d
Days
Class 2
Risk

K991277 is an FDA 510(k) clearance for the MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5. 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 April 27, 1999 after a review of 13 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 - K991277

510(k) Number K991277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1999
Decision Date April 27, 1999
Days to Decision 13 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
75d faster than avg
Panel avg: 88d · This submission: 13d
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 K991277.
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
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp. · Jun 1999
OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
K984145 · Olympus Diagnostica GmbH · Dec 1998
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · Dade Behring, Inc. · Dec 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · Dade Behring, Inc. · Dec 1998
K991277 · MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5
Download PDF FDA Summary Diagnostic Products C…