Cleared Traditional

K981099 - STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK

K981099 is an FDA 510(k) clearance for STRATUS CS STAT FLUOROMETRIC ANALYZER A..., manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K981099 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
61d
Days
Class 2
Risk

K981099 is an FDA 510(k) clearance for the STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 26, 1998 after a review of 61 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 Dade Behring, Inc. devices

FDA 510(k) Submission Details - K981099

510(k) Number K981099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1998
Decision Date May 26, 1998
Days to Decision 61 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 88d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K981099.
VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
K993068 · Ortho-Clinical Diagnostics · Oct 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · Diagnostic Products Corp. · Jun 1999
STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK
K984067 · Dade Behring, Inc. · Jan 1999
CREATINE KINASE REAGENT
K980012 · Ac Biochemicals, Inc. · Feb 1998
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
DADE STRATUS CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
K972782 · Dade Intl., Inc. · Aug 1997