Cleared Traditional

PASCO MIC AND MIC/ID PANELS (K935805) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K935805 · Pasco Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
193d
Days
Class 2
Risk

K935805 is an FDA 510(k) clearance for the PASCO MIC AND MIC/ID PANELS. Classified as Susceptibility Test Powders, Antimicrobial (product code JTT), Class II - Special Controls.

Submitted by Pasco Laboratories, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on June 13, 1994 after a review of 193 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Pasco Laboratories, Inc. devices

Submission Details

510(k) Number K935805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1993
Decision Date June 13, 1994
Days to Decision 193 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 102d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTT Susceptibility Test Powders, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JTT Susceptibility Test Powders, Antimicrobial

All 13
Devices cleared under the same product code (JTT) and FDA review panel - the closest regulatory comparables to K935805.
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K855106 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986
ANTITUBERCULOUS DRUGS (SIRE)
K822329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982