Cleared Traditional

K892216 - GEN-PROBE PACE SYSTEM URINE SCREEN

K892216 is an FDA 510(k) clearance for GEN-PROBE PACE SYSTEM URINE SCREEN, manufactured by Gen-Probe, Inc.. The device is a Class 1 Microbiology device with product code JXA cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K892216 · Gen-Probe, Inc. · Microbiology device
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Sep 1989
Decision
165d
Days
Class 1
Risk

K892216 is an FDA 510(k) clearance for the GEN-PROBE PACE SYSTEM URINE SCREEN. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on September 15, 1989 after a review of 165 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gen-Probe, Inc. devices

FDA 510(k) Submission Details - K892216

510(k) Number K892216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1989
Decision Date September 15, 1989
Days to Decision 165 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 102d · This submission: 165d
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 10
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K892216.
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
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
ORTHO BACTERIURIA DETECTION SYS
K833834 · Ortho Diagnostic Systems, Inc. · Mar 1984
DIPCHEX DIP-SLIDE CULTURE SYS
K830252 · Granite Diagnostics, Inc. · Mar 1983