Cleared Special

K991795 - IMMULITE TURBO TROPONIN I

K991795 is the FDA 510(k) clearance for IMMULITE TURBO TROPONIN I by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code MMI) cleared through the Special 510(k) pathway after a 14-day FDA review.

K991795 · Diagnostic Products Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
14d
Days
Class 2
Risk

K991795 is an FDA 510(k) clearance for the IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5. Classified as Immunoassay Method, Troponin Subunit (product code MMI), 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.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K991795 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.

Device Classification

Product Code MMI Immunoassay Method, Troponin Subunit
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 - MMI Immunoassay Method, Troponin Subunit

All 62
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K991795.
TROPONIN I ASSAY FOR THE BAYER IMMUNO 1 SYSTEM ( IN VITRO DIAGNOSTIC SYSTEM)
K993353 · Bayer Corp. · Dec 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK
K992366 · Ortho-Clinical Diagnostics, Inc. · Oct 1999
OPUS TROPONIN I (CTN) TEST MODULES
K991177 · Dade Behring, Inc. · Jul 1999
STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK
K984093 · Dade Behring, Inc. · Dec 1998
ELECSYS TROPONIN T STAT TEST
K984105 · Boehringer Mannheim Corp. · Dec 1998
IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15
K983972 · Diagnostic Products Corp. · Dec 1998