Cleared Traditional

K811680 - ACCUDEX

K811680 is an FDA 510(k) clearance for ACCUDEX, manufactured by Biodynamics Corp.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K811680 · Biodynamics Corp. · Chemistry device
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Jul 1981
Decision
38d
Days
Class 1
Risk

K811680 is an FDA 510(k) clearance for the ACCUDEX. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Biodynamics Corp. (Mchenry, US). The FDA issued a Cleared decision on July 23, 1981 after a review of 38 days - a notably fast clearance cycle.

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: 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 Biodynamics Corp. devices

FDA 510(k) Submission Details - K811680

510(k) Number K811680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1981
Decision Date July 23, 1981
Days to Decision 38 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 88d · This submission: 38d
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 161
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K811680.
4050/4051 ULTRASPEC
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QUANTUMATIC DUAL-WAVELENGTH SPECTRO
K812865 · Abbott Laboratories · Nov 1981
QUICK-CHEM COLORIMETER
K811806 · The Dow Chemical Co. · Jul 1981
GILUCOCHEK REFLECTANCE METER
K810665 · Lifescan, Inc. · Apr 1981
BECKMAN DU-8 SPECTROPHOTOMETER
K810511 · Beckman Instruments, Inc. · Mar 1981