Cleared Traditional

K895215 - PASCO MIC/ID GRAM-POSITIVE PANEL

K895215 is an FDA 510(k) clearance for PASCO MIC/ID GRAM-POSITIVE PANEL, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K895215 · Difco Laboratories, Inc. · Microbiology device
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Jan 1990
Decision
164d
Days
Class 2
Risk

K895215 is an FDA 510(k) clearance for the PASCO MIC/ID GRAM-POSITIVE PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on January 29, 1990 after a review of 164 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 Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K895215

510(k) Number K895215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1989
Decision Date January 29, 1990
Days to Decision 164 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
62d slower than avg
Panel avg: 102d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K895215.
PASCO MIC AND MIC/ID MODIFIED
K902739 · Pasco Laboratories, Inc. · Jul 1990
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVE
K896566 · Medical Specialties, Inc. · Feb 1990
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K896965 · Alamar Biosciences Laboratory, Inc. · Jan 1990
API UNISCEPT KB
K895796 · Analytical Products, Inc. · Nov 1989
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K894514 · Alamar Biosciences Laboratory, Inc. · Nov 1989