Cleared Traditional

K884085 - TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY

K884085 is an FDA 510(k) clearance for TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY, manufactured by Hybritech, Inc.. The device is a Class 2 Chemistry device with product code JHY cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K884085 · Hybritech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1988
Decision
66d
Days
Class 2
Risk

K884085 is an FDA 510(k) clearance for the TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on December 2, 1988 after a review of 66 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 Hybritech, Inc. devices

FDA 510(k) Submission Details - K884085

510(k) Number K884085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1988
Decision Date December 02, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 88d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHY Device Classification - Class 2, Special Controls

Product Code JHY Colorimetric 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 - JHY Colorimetric Method, Cpk Or Isoenzymes

All 36
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K884085.
ISOSCREEN-CK CONFIRMATORY KIT
K895870 · Roche Diagnostic Systems, Inc. · Dec 1989
TARGET(TM) CK-MB
K890295 · V-Tech, Inc. · Aug 1989
CREATINE KINASE MB ENZYME IMMUNOASSAY KIT
K884550 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
IMX CKMB
K883013 · Abbott Laboratories · Aug 1988
IMACK-MB, CATALOGS 602-1, 602-1/125, 602-1/225
K881351 · Intl. Immunoassay Laboratories, Inc. · Jun 1988
KODAK EKTACHEM DT SLIDES (CKMB)
K875192 · Eastman Kodak Company · Feb 1988