Cleared Traditional

K874620 - GEN-PROBE PACE SYSTEM FOR NEISSERIA GON...

K874620 is an FDA 510(k) clearance for GEN-PROBE PACE SYSTEM FOR NEISSERIA GON..., manufactured by Gen-Probe, Inc.. The device is a Class 2 Microbiology device with product code LSL cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K874620 · Gen-Probe, Inc. · Microbiology device
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Mar 1988
Decision
113d
Days
Class 2
Risk

K874620 is an FDA 510(k) clearance for the GEN-PROBE PACE SYSTEM FOR NEISSERIA GONORRHOEAE. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on March 1, 1988 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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 - K874620

510(k) Number K874620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date March 01, 1988
Days to Decision 113 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
11d slower than avg
Panel avg: 102d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LSL Device Classification - Class 2, Special Controls

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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 Microbiology devices follow this clearance model.

Regulatory Peers - LSL Dna-reagents, Neisseria

All 36
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K874620.
PACE 2 NEISSERIA GONORRHOEAE PROBE CONFIRM. ASSAY
K920301 · Gen-Probe, Inc. · Apr 1994
ACCUPROBE NEISSERIA GONORRHOEAE CULTURE CONFIRMA.
K895583 · Gen-Probe, Inc. · Nov 1989
PACE SYSTEM FOR NEISSERIA GONORRHOEAE ADDI. CLAIMS
K881277 · Gen-Probe, Inc. · Apr 1988
GONOSPOT* DNA PROBE CULTURE CONFIRMATION TEST
K872628 · Ortho Diagnostic Systems, Inc. · Dec 1987