Cleared Traditional

K842717 - COBAS-FIBRO

K842717 is an FDA 510(k) clearance for COBAS-FIBRO, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K842717

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.

JPA Device Classification - Class 2, Special Controls

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 155
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K842717.
CITREX III
K853078 · Bio/Data Corp. · Aug 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
HEPARIN COAGULATION CONTROL PLASMA 1-
K841462 · Diatech, Inc. · Jun 1984
OWREN'S VERONAL BUFFERR
K841523 · Diatech, Inc. · Jun 1984
THROMBOPLASTIN - FS
K833272 · American Dade · Nov 1983