Cleared Traditional

K983704 - MODIFICATION TO ABUSCREEN ONLINE FOR PH...

K983704 is the FDA 510(k) clearance for MODIFICATION TO ABUSCREEN ONLINE FOR PH... by Roche Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code JCM) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K983704 · Roche Diagnostic Systems, Inc. · Toxicology device
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Feb 1999
Decision
112d
Days
Class 2
Risk

K983704 is an FDA 510(k) clearance for the MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE. Classified as Control, Hemoglobin, Abnormal (product code JCM), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on February 10, 1999 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 864.7415 - the FDA toxicology 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K983704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1998
Decision Date February 10, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 87d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JCM Control, Hemoglobin, Abnormal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7415
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 Toxicology devices follow this clearance model.

Regulatory Peers - JCM Control, Hemoglobin, Abnormal

All 7
Devices cleared under the same product code (JCM) and FDA review panel - the closest regulatory comparables to K983704.
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K942222 · Isolab, Inc. · Jan 1995
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
K933086 · Helena Laboratories · Oct 1994
HEMOCARD CONTROL HB-AA, AE, FAA, FAE
K931234 · Isolab, Inc. · May 1993
HEMOCARD(TM) CONTROL
K924173 · Isolab, Inc. · Dec 1992
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · Bio-Rad · Jun 1991
HEMOCARD CONTROL
K910431 · Isolab, Inc. · Mar 1991