Cleared Traditional

K926248 - READER

K926248 is an FDA 510(k) clearance for READER, manufactured by Alamar Biosciences Laboratory, Inc.. The device is a Class 1 Microbiology device with product code LRH cleared through the Traditional 510(k) pathway after a 519-day FDA review.

K926248 · Alamar Biosciences Laboratory, Inc. · Microbiology device
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May 1994
Decision
519d
Days
Class 1
Risk

K926248 is an FDA 510(k) clearance for the READER. Classified as Instrument For Auto Reader Of Overnight Microorganism Identification System (product code LRH), Class I - General Controls.

Submitted by Alamar Biosciences Laboratory, Inc. (Sacramento, US). The FDA issued a Cleared decision on May 17, 1994 after a review of 519 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Alamar Biosciences Laboratory, Inc. devices

FDA 510(k) Submission Details - K926248

510(k) Number K926248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date May 17, 1994
Days to Decision 519 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
417d slower than avg
Panel avg: 102d · This submission: 519d
Pathway characteristics
Predicate-based equivalence.

LRH Device Classification - Class 1, General Controls

Product Code LRH Instrument For Auto Reader Of Overnight Microorganism Identification System
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 - LRH Instrument For Auto Reader Of Overnight Microorganism Identification System

Devices cleared under the same product code (LRH) and FDA review panel - the closest regulatory comparables to K926248.
GRAM NEGATIVE IDENTIFICATION PLUS CARD
K962609 · Biomerieux Vitek, Inc. · Aug 1996
MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL
K961042 · Dade Microscan, Inc. · May 1996
AUTOSCEPTOR IDENTIFICATION SYSTEM
K920225 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1992