Cleared Special

MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 (K991277) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K991277 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (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.

View all Diagnostic Products Corp. devices

Submission Details

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.

Device Classification

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 45
Devices cleared under the same product code (DDR) and FDA review panel - the closest regulatory comparables to K991277.
Access Myoglobin
K231832 · Beckman Coulter, Inc. · Sep 2023
QUANTEX MYOGLOBIN
K042982 · Instrumentation Laboratory CO · Dec 2004
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · Diagnostic Products Corp. · Jun 1999
STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK
K984065 · Dade Behring, Inc. · Dec 1998
MYOGLOBIN FLEX REAGENT CARTRIDGE
K984191 · Dade Behring, Inc. · Dec 1998
IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5
K983970 · Diagnostic Products Corp. · Nov 1998