Cleared Traditional

K892060 - CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM

K892060 is the FDA 510(k) clearance for CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM by Syva Co.. It is a Class 1 Chemistry device (product code JQP) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K892060 · Syva Co. · Chemistry device
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Aug 1989
Decision
134d
Days
Class 1
Risk

K892060 is an FDA 510(k) clearance for the CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 10, 1989 after a review of 134 days - within the typical 510(k) review window.

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 Syva Co. devices

Submission Details

510(k) Number K892060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1989
Decision Date August 10, 1989
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
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 46
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K892060.
EXPRESSO CARTRIDGE
K923316 · Bio-Rad Laboratories, Inc. · Feb 1993
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
K893838 · Ciba Corning Diagnostics Corp. · Aug 1989
COBAS MFC
K885292 · Roche Diagnostic Systems, Inc. · Mar 1989
KALLESTAD QM300 PROTEIN ANALYSIS SYSTEM
K871339 · Kallestad Diag, A Div. of Erbamont, Inc. · May 1987
710 PLUS
K864557 · Ciba Corning Diagnostics Corp. · Feb 1987
GLUCOFACTS DATA MANAGEMENT SYSTEM
K861844 · Miles Laboratories, Inc. · Aug 1986