Cleared Traditional

K842717 - COBAS-FIBRO

K842717 is the FDA 510(k) clearance for COBAS-FIBRO by Roche Diagnostic Systems, Inc.. It is a Class 2 Hematology device (product code JPA) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K842717 · Roche Diagnostic Systems, Inc. · Hematology device
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Oct 1984
Decision
96d
Days
Class 2
Risk

K842717 is an FDA 510(k) clearance for the COBAS-FIBRO. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on October 17, 1984 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K842717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1984
Decision Date October 17, 1984
Days to Decision 96 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 113d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 Hematology devices follow this clearance model.

Regulatory Peers - JPA System, Multipurpose For In Vitro Coagulation Studies

All 99
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K842717.
KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS
K853328 · Ortho Diagnostic Systems, Inc. · Nov 1985
DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO
K851127 · E.I. Dupont DE Nemours & Co., Inc. · May 1985
GEN. DIAG. CHROMOSTRATE REF. PLASMA
K850409 · Warner-Lambert Co. · May 1985
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983
ORTHO ABNORMAL COAGULATION LEVEL I/II
K832225 · Ortho Diagnostic Systems, Inc. · Aug 1983
DIGICLOT 2-#820
K812121 · Volu Sol Medical Industries · Nov 1981