Cleared Traditional

K030067 - VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS

K030067 is an FDA 510(k) clearance for VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG ..., manufactured by Ortho-Clinical Diagnostics. The device is a Class 1 Microbiology device with product code MJX cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K030067 · Ortho-Clinical Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
10d
Days
Class 1
Risk

K030067 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS. Classified as Kit, Serological, Positive Control (product code MJX), Class I - General Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.1660 - the FDA microbiology 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ortho-Clinical Diagnostics devices

FDA 510(k) Submission Details - K030067

510(k) Number K030067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2003
Decision Date January 17, 2003
Days to Decision 10 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 102d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

MJX Device Classification - Class 1, General Controls

Product Code MJX Kit, Serological, Positive Control
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 - MJX Kit, Serological, Positive Control

Devices cleared under the same product code (MJX) and FDA review panel - the closest regulatory comparables to K030067.
AUDIT MICROCV PROCALCITONIN LINEARITY
K101434 · Aalto Scientific, Ltd. · Jul 2010
SYSCOS IDC - G, IDC, BSC, IDC - G
K974262 · Scantibodies Laboratory, Inc. · Dec 1997
ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
K972986 · Boston Biomedica, Inc. · Oct 1997
TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL
K970100 · Simplicity Diagnostics, Inc. · Mar 1997
OPUS(R) SEROLOGY CONTROLS, MODIFICATION
K934137 · Pb Diagnostic Systems, Inc. · Mar 1994