# K993755: Emit Calibrater/Control Level 0, Level 1, Level 2, Level 3, Level 4, Level 5

- Pathway: 510(k) (Abbreviated)
- Applicant: Syva Co.
- Decided: Dec 21, 1999 after 46 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 devices 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) Emit Calibrator Level 0: named in the summary without a submission number
- (no number) Emit Calibrators A Level 1 and 2: named in the summary without a submission number
- (no number) Emit Calibrators B Level 1 and 2: named in the summary without a submission number

## Most influential descendants
- K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls (2005), 6 descendants of its own
- K153693: Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2016), 0 descendants of its own
- K151771: Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2016), 0 descendants of its own
- K152176: Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators (2015), 0 descendants of its own
- K143502: Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls (2015), 0 descendants of its own

## Indications for use
The Emit Calibrator/Controls are used in the calibration of the Emit Il Plus drugs-of-abuse assays. These standards may also be used as quality control materials based upon specified assay cutoff levels. The Emit Calibrator/Controls are used for the Emit Il Plus Barbiturate, Benzodiazepine, Cannabinoid, Cocaine Metabolite, Methadone, Methaqualone, Mononclonal Amphetamine/Methamphetamine, Opiates, Phencyclidine, and Propoxyphene Assays. Note:The above listed assays are currently in the process of being filed for 510(k) clearance.

Source page: https://510kreport.com/device/K993755
Methodology: https://510kreport.com/methodology