# K973628: Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva

- Pathway: 510(k) (Traditional)
- Applicant: Vital Scientific N.V.
- Decided: Mar 13, 1998 after 170 days
- Product code: JJF (Analyzer, Chemistry, Micro, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2170
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Roche Cobas Mira: named in the summary without a submission number

## Most influential descendants
- K093883: Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250, Assl-0455, Cali-0580, Cont-0080, Cont- (2010), 0 descendants of its own

## Recalls of this device
- Nov 15, 2018 · Class II · Z-0547-2020: During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample container resulting in a sample result and pa
- Jan 18, 2016 · Class II · Z-2558-2019: Instrument stopped working due to a software lockup, and no patient results are produced.
- Jan 10, 2012 · Class II · Z-0156-2020: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- Jan 10, 2012 · Class II · Z-0155-2020: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.
- Jan 10, 2012 · Class II · Z-0154-2020: The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

## Indications for use
This notification is for an in vitro diagnostic device, which is an automated chemistry analyzer, micro type, intended for clinical use in conjunction with certain materials to measure a variety of analytes, including applications in clinical chemistry, monitoring drugs of abuse and in therapeutic drug monitoring.

Source page: https://510kreport.com/device/K973628
Methodology: https://510kreport.com/methodology