Cleared Traditional

K942250 - BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER

K942250 is an FDA 510(k) clearance for BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA..., manufactured by Biowhittaker Molecular Applications, Inc.. The device is a Class 1 Microbiology device with product code JJQ cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K942250 · Biowhittaker Molecular Applications, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1995
Decision
330d
Days
Class 1
Risk

K942250 is an FDA 510(k) clearance for the BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on April 4, 1995 after a review of 330 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2300 - 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. Elevated predicate reliance profile. 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 Biowhittaker Molecular Applications, Inc. devices

FDA 510(k) Submission Details - K942250

510(k) Number K942250 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1994
Decision Date April 04, 1995
Days to Decision 330 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
228d slower than avg
Panel avg: 102d · This submission: 330d
Pathway characteristics
Predicate-based equivalence.

JJQ Device Classification - Class 1, General Controls

Product Code JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2300
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 - JJQ Colorimeter, Photometer, Spectrophotometer For Clinical Use

All 166
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