Cleared Traditional

K925188 - ABBOTT QUICKSTART LD-1, MODIFICATION

K925188 is an FDA 510(k) clearance for ABBOTT QUICKSTART LD-1, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code JGF cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K925188 · Em Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
120d
Days
Class 2
Risk

K925188 is an FDA 510(k) clearance for the ABBOTT QUICKSTART LD-1, MODIFICATION. Classified as Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (product code JGF), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K925188

510(k) Number K925188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1992
Decision Date February 05, 1993
Days to Decision 120 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 88d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGF Device Classification - Class 2, Special Controls

Product Code JGF Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
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 - JGF Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes

Devices cleared under the same product code (JGF) and FDA review panel - the closest regulatory comparables to K925188.
LD-1
K981338 · Abbott Laboratories · May 1998
ABBOTT QUICKSTART LD-1,#5A30
K914261 · Em Diagnostic Systems, Inc. · Oct 1991
LD1 ISOENZYME REAGENT KIT
K890996 · Trace Scientific , Ltd. · May 1989
ABBOTT A-GENT LD-1 ISOZYME REAGENT
K871240 · Abbott Laboratories · May 1987
MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)
K860367 · Alpkem Corp. · Apr 1986