510(k) · Cleared

Recalled · Class II · 2018

Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva

K973628510(k) TraditionalCleared Mar 13, 1998170-day reviewClass I21 CFR 862.2170Recalls 5

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Vital Scientific N.V. · JJF Analyzer, Chemistry, Micro, For Clinical Use

Cleared on Mar 13, 1998 after a 170-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 5 times.

Decided: Mar 13, 1998
Review: 170 days
Class: Class I
Product code: JJF
Recalls: 5
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK973628 Vitalab Flexor/Vitalab Selectra 2/Vitalab VivaVital Scientific N.V. · 1998
Descendant · cites it directly · 0 of its ownK093883 Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II…Seppim S.A.S. · 2010

Most influential descendants

Showing 1 of 1 · See all

K093883Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…Seppim S.A.S. · 2010 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973628	Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva	Vital Scientific N.V.	1998	—
+1	K093883	Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model…	Seppim S.A.S.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K973628, 1998–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JJF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Roche Cobas Mira Named without a submission number			—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093883	Ast/Got 4+1 SL, Ast/Got 4+1 SL, Elical 2, Elitrol I, Elitrol II, Model Assl-0250…	Seppim S.A.S.	2010	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 15, 2018	Class II	Z-0547-2020	Nonconforming Material/Component	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 patient ID mismatch. If not detected…
Jan 18, 2016	Class II	Z-2558-2019	Software Manufacturing/Software Deployment	Instrument stopped working due to a software lockup, and no patient results are produced.
Jan 10, 2012	Class II	Z-0156-2020	Component design/selection	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	Component design/selection	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	Component design/selection	The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K093883 (Seppim S.A.S., 2010) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JJF devices

JJF Analyzer, Chemistry, Micro, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJF

FDA has decided no JJF device since 2007.

Median 510(k) review, days · JJF

Too few JJF 510(k)s in any year since 2007 to give a median.

Recalls per year · JJF

2in 2018

2007high 3 (2012) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JJF

2in 2025

2007high 21 (2010) · low 0 (2015)2025

MAUDE reports naming product code JJF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	—	2	10
2008	—	0	2
2009	—	0	3
2010	—	0	21
2011	—	0	19
2012	—	3	8
2013	—	0	1
2014	—	0	3
2015	—	0	0
2016	—	0	0
2017	—	0	0
2018	—	2	0
2019	—	0	0
2020	—	0	0
2021	—	0	0
2022	—	0	1
2023	—	0	1
2024	—	0	0
2025	—	0	2
2026	—	0	—

What is it indicated for?

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973628 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973628: Vitalab Flexor/Vitalab Selectra 2/Vitalab Viva.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973628

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026