Cleared Traditional

K821514 - TECHNICON RA-1000 SYS, ANALYTES III

K821514 is an FDA 510(k) clearance for TECHNICON RA-1000 SYS, manufactured by Technicon Instruments Corp.. The device is a Class 2 Chemistry device with product code JEJ cleared through the Traditional 510(k) pathway .

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

FDA 510(k) Submission Details - K821514

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
Combination Product No
PCCP Authorized No
Regulatory Context
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEJ Device Classification - Class 2, Special Controls

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.