Cleared Traditional

EXPRESSO CARTRIDGE (K923316) - FDA 510(k) Clearance

Class I Chemistry device.

K923316 · Bio-Rad Laboratories, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
231d
Days
Class 1
Risk

K923316 is an FDA 510(k) clearance for the EXPRESSO CARTRIDGE. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Bio-Rad Laboratories, Inc. (Chaska, US). The FDA issued a Cleared decision on February 23, 1993 after a review of 231 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Bio-Rad Laboratories, Inc. devices

Submission Details

510(k) Number K923316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date February 23, 1993
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 77
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K923316.
CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM
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EMIT CLINICAL PROCESSOR #CP-5000
K822932 · Syva Co. · Nov 1982
SYVA LAB PROCESSOR 6000
K822381 · Syva Co. · Aug 1982
EMIT TIMER UNIT #100
K821531 · Syva Co. · Jun 1982
EMIT CLINICAL PROCESSOR-CP 5000
K792129 · Syva Co. · Nov 1979