Cleared Traditional

K900719 - ROTAG CONTROLS

K900719 is an FDA 510(k) clearance for ROTAG CONTROLS, manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 1 Chemistry device with product code JJX cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K900719 · Roche Diagnostic Systems, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1990
Decision
105d
Days
Class 1
Risk

K900719 is an FDA 510(k) clearance for the ROTAG CONTROLS. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on May 30, 1990 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K900719

510(k) Number K900719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1990
Decision Date May 30, 1990
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 88d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

JJX Device Classification - Class 1, General Controls

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

All 436
Devices cleared under the same product code (JJX) and FDA review panel - the closest regulatory comparables to K900719.
CHEM-CHEX-ALT
K903147 · Streck Laboratories, Inc. · Aug 1990
AMERSHAM TSH CONTROL SERA
K902760 · Amersham Corp. · Jul 1990
CHEM-CHEX BILIRUBIN
K902867 · Streck Laboratories, Inc. · Jul 1990
POSITIVE AND NEGATIVE HCG SERUM CONTROLS
K896875 · Armkel, LLC · Feb 1990
GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104
K895528 · Helena Laboratories · Oct 1989
MICRO-PLATE READER, MDX-1
K894400 · Medix Biotech, Inc. · Oct 1989