Cleared Traditional

CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM (K892060) - FDA 510(k) Clearance

Class I Chemistry device.

K892060 · Syva Co. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 77
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K892060.
SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER
K850659 · Syva Co. · Apr 1985
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
THE ABBOTT EXECUTIVE
K790543 · Abbott Laboratories · May 1979