Cleared Traditional

K850993 - SMART ALEX II MULTI-FILTER PHOTOMETER

K850993 is an FDA 510(k) clearance for SMART ALEX II MULTI-FILTER PHOTOMETER, manufactured by Awareness Technology, Inc.. The device is a Class 1 Chemistry device with product code JJQ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K850993 · Awareness Technology, Inc. · Chemistry device
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May 1985
Decision
57d
Days
Class 1
Risk

K850993 is an FDA 510(k) clearance for the SMART ALEX II MULTI-FILTER PHOTOMETER. Classified as Colorimeter, Photometer, Spectrophotometer For Clinical Use (product code JJQ), Class I - General Controls.

Submitted by Awareness Technology, Inc. (Palm City, US). The FDA issued a Cleared decision on May 7, 1985 after a review of 57 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 Awareness Technology, Inc. devices

FDA 510(k) Submission Details - K850993

510(k) Number K850993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1985
Decision Date May 07, 1985
Days to Decision 57 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
31d faster than avg
Panel avg: 88d · This submission: 57d
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 160
Devices cleared under the same product code (JJQ) and FDA review panel - the closest regulatory comparables to K850993.
NOVASPEC VISIBLE SPECTROPHOTOMETER
K851572 · Lkb Instruments, Inc. · May 1985
SPECTRA 1 FILTER PHOTOMETER
K850994 · Awareness Technology, Inc. · May 1985
SMART ALEX COMPACT CLINICAL ANALYZER(CCA)(FILTER P
K850995 · Awareness Technology, Inc. · May 1985
BEHRING VECTOR PHOTOMETER
K851098 · Behring Diagnostics, Inc. · Apr 1985
INTELLIGENT PHOTOMETERS MCP, IFP, ISP, FPS, SPS
K850392 · Clinical Data, Inc. · Apr 1985
TITERTEK MULTISKAN MCC
K844418 · Flow Laboratories, Inc. · Mar 1985