# K971600: Emit Calibrator B Level 1 (Cutoff)/Emit Calibrator B Level 2 (High)

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Jun 25, 1997 after 55 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
Longest line of descent: 1 generation back to K912729 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K912729: Emit Calibrator B Level 1(Cutoff) & Level 2(High), Syva Co. (1991) Summary page 1.

## Indications for use
The Emit® Calibrator B Level 1 and Calibrator B Level 2 are used in the calibration of the Emit® d.a.u.™ Amphetamine Class, Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Cocaine Metabolite (150 ng/mL cutoff), Methadone, Methaqualone, and Propoxyphene Assays. The Emit® Calibrator B Level 1 and Calibrator B Level 2 are also used in the calibration of the Emit® IT Barbiturate (300 ng/mL cutoff), Benzodiazepine (300 ng/mL cutoff), Methadone, Methaqualone, Opiates 300/2000, and Propoxyphene Assays.

Source page: https://510kreport.com/device/K971600
Methodology: https://510kreport.com/methodology