Cleared Traditional

K983704 - MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE

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

K983704 · Roche Diagnostic Systems, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K983704

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.

JCM Device Classification - Class 2, Special Controls

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 9
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
SICKLE HEMOGLOBIN (HBA/S) CONTROL SET
K913427 · Creative Laboratory Products, Inc. · Nov 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
K911347 · Bio-Rad · Jun 1991