Cleared Traditional

UBIT-IR300 INFRARED SPECTROMETRY SYSTEM (K013371) - FDA 510(k) Clearance

Class I Microbiology device.

K013371 · Otsuka Pharmaceutical Co., Ltd. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2001
Decision
71d
Days
Class 1
Risk

K013371 is an FDA 510(k) clearance for the UBIT-IR300 INFRARED SPECTROMETRY SYSTEM. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Otsuka Pharmaceutical Co., Ltd. (North Attleboro, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Otsuka Pharmaceutical Co., Ltd. devices

Submission Details

510(k) Number K013371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 2001
Decision Date December 21, 2001
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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

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