Cleared Traditional

K821514 - TECHNICON RA-1000 SYS, ANALYTES III (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K821514 · Technicon Instruments Corp. · Chemistry device
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May 1982
Decision
-
Days
Class 2
Risk

K821514 is an FDA 510(k) clearance for the TECHNICON RA-1000 SYS, ANALYTES III. Classified as Tubing, Instrumentation, Bronchoscope (brush Sheath A/o Aspirating) (product code JEJ), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Mchenry, US). The FDA issued a Cleared decision on May 10, 1982.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 874.4680 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K821514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1982
Decision Date May 10, 1982
Days to Decision -
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEJ Tubing, Instrumentation, Bronchoscope (brush Sheath A/o Aspirating)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.