Cleared Traditional

K911045 - OBA(TM) READER

K911045 is an FDA 510(k) clearance for OBA(TM) READER, manufactured by Adeza Biomedical. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K911045 · Adeza Biomedical · Chemistry device
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Jun 1991
Decision
108d
Days
Class 1
Risk

K911045 is an FDA 510(k) clearance for the OBA(TM) READER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Adeza Biomedical (Sunnyvale, US). The FDA issued a Cleared decision on June 24, 1991 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2300 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Adeza Biomedical devices

FDA 510(k) Submission Details - K911045

510(k) Number K911045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1991
Decision Date June 24, 1991
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K911045.
OPUS(R) PLUS ANALYZER
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CHEM-LINK DATA BASE MANAGER
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K911438 · Bio-Tek Instruments, Inc. · May 1991
DYNATECH MR4000 MICROPLATE READER
K904567 · Dynatech Corp. · Jan 1991
GEN-PROBE LUMINOMETER-LEADER 450
K905762 · Gen-Probe, Inc. · Jan 1991