# K973894: Immusure

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Oct 29, 1997 after 15 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tri-Point™ Brand Liquimmune® Liquid Assayed Immunoassay Controls: named in the summary without a submission number
- (no number) Dade® Immunoassay Controls Comprehensive Tri-Level: named in the summary without a submission number
- (no number) Liquichek™ Immunoassay Plus Control: named in the summary without a submission number

## Indications for use
The Quantimetrix Immusure Immunoassay/TDM Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure the serum analytes and therapeutic drugs contained in the control. It is intended to validate the measurement of these analytes and drugs in patient serum samples. Quality Control materials having known component concentrations are an integral part of diagnostic procedures. Daily monitoring of control values establishes intralaboratory parameters for accuracy and precision of the test method. CLIA regulation 493.1202(C)(4) requires labs to perform and document control procedures for each day of testing. Three levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

Source page: https://510kreport.com/device/K973894
Methodology: https://510kreport.com/methodology