Cleared Traditional

K933885 - ALAMAR BIOSCIENCES LABORATORY

K933885 is an FDA 510(k) clearance for ALAMAR BIOSCIENCES LABORATORY, manufactured by Alamar Biosciences, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K933885 · Alamar Biosciences, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
98d
Days
Class 2
Risk

K933885 is an FDA 510(k) clearance for the ALAMAR BIOSCIENCES LABORATORY, INC. ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Alamar Biosciences, Inc. (Sacramento, US). The FDA issued a Cleared decision on November 16, 1993 after a review of 98 days - within the typical 510(k) review window.

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 Alamar Biosciences, Inc. devices

FDA 510(k) Submission Details - K933885

510(k) Number K933885 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1993
Decision Date November 16, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 102d · This submission: 98d
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 392
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K933885.
PASCO MIC AND MIC/ID PANELS
K933709 · Pasco Laboratories, Inc. · Dec 1993
PASCO MIC AND MIC/ID PANELS
K933746 · Pasco Laboratories, Inc. · Dec 1993
PASCO MIC AND MIC/ID PANELS
K933849 · Pasco Laboratories, Inc. · Nov 1993
PASCO MIC AND MIC/ID PANELS
K932917 · Pasco Laboratories, Inc. · Aug 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K932082 · Baxter Diagnostics, Inc. · Jul 1993
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K930469 · Alamar Biosciences Laboratory, Inc. · Jun 1993