Cleared Traditional

K890543 - IMPRES-MB REAGENT A AND REAGENT B

K890543 is the FDA 510(k) clearance for IMPRES-MB REAGENT A AND REAGENT B by Intl. Immunoassay Laboratories, Inc.. It is a Class 2 Chemistry device (product code JHX) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K890543 · Intl. Immunoassay Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1989
Decision
38d
Days
Class 2
Risk

K890543 is an FDA 510(k) clearance for the IMPRES-MB REAGENT A AND REAGENT B. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Intl. Immunoassay Laboratories, Inc. (Santa Clara, US). The FDA issued a Cleared decision on March 13, 1989 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intl. Immunoassay Laboratories, Inc. devices

Submission Details

510(k) Number K890543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1989
Decision Date March 13, 1989
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHX Fluorometric Method, Cpk Or Isoenzymes
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 - JHX Fluorometric Method, Cpk Or Isoenzymes

All 30
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K890543.
TRIAGE CARDIAC PANEL, TRIAGE TROPONIN-I, TRIAGE CK-MB, TRIAGE MYOGLOBIN, TRIAGE TROPONIN-I AND CK-MB, TRIAGE TROPONIN-I
K973126 · Biosite Incorporated · Oct 1997
VIDAS CREATINE KINASE MB ASSAY 30-421
K962549 · Biomerieux Vitek, Inc. · Aug 1996
CIBA CORNING ACS CKMB IMMUNOASSAY
K911121 · Ciba Corning Diagnostics Corp. · Apr 1991
BIOTROL CK MONOEACTIF
K881267 · Biotrol, USA, Inc. · May 1988
TITAN GEL REP CPK-6 HV
K874144 · Helena Laboratories · Nov 1987
TITAN GEL CPK REP SYSTEM
K873399 · Helena Laboratories · Oct 1987