Cleared Traditional

K833834 - ORTHO BACTERIURIA DETECTION SYS

K833834 is an FDA 510(k) clearance for ORTHO BACTERIURIA DETECTION SYS, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 1 Immunology device with product code JXA cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K833834 · Ortho Diagnostic Systems, Inc. · Immunology device
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Mar 1984
Decision
130d
Days
Class 1
Risk

K833834 is an FDA 510(k) clearance for the ORTHO BACTERIURIA DETECTION SYS. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2660 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K833834

510(k) Number K833834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1983
Decision Date March 12, 1984
Days to Decision 130 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 105d · This submission: 130d
Pathway characteristics
Predicate-based equivalence.

JXA Device Classification - Class 1, General Controls

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JXA Kit, Screening, Urine

All 12
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K833834.
SLIDE CULTURE U 'EIKEN'
K861631 · Syn-Kit, Inc. · Jun 1986
URICHECK
K860905 · Difco Laboratories, Inc. · Apr 1986
BAC-T-SCREEN
K851399 · Marion Laboratories, Inc. · Jun 1985
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · Granite Diagnostics, Inc. · Mar 1983
BAC-T-SCREEN BACTERIURIA DETECTION DEV
K823850 · Marion Laboratories, Inc. · Mar 1983
MS-2 AUTOMATED URINE SCREENING SYSTEM
K781370 · Abbott Laboratories · Sep 1978