# K960244: Document TDM Ultra Assayed Control

- Pathway: 510(k) (Traditional)
- Applicant: Casco Standards
- Decided: Mar 22, 1996 after 66 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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) Dade Immunoassay Controls Comprehensive Tri-Level, Levels 1, 2, and 3: named in the summary without a submission number
- (no number) Instrumentation Laboratory TheraChem TDC Therapeutic Drug Controls, Low and High Levels: named in the summary without a submission number
- (no number) Abbott REA Ethanol Serum Control, Levels L, M, and H: named in the summary without a submission number

## Indications for use
This product is intended for in vitro diagnostic use as a control product to assess the analytical performance of immunochemistry systems and clinical chemistry systems using methods for the quantitative measurement of the listed analytes. It is intended to provide the necessary control material required by inspection agencies for the evaluation of system performance. In addition, it will provide assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.

Source page: https://510kreport.com/device/K960244
Methodology: https://510kreport.com/methodology