# K961510: Acs FRT4 Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Jun 17, 1996 after 59 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) Ameriex-MAB FT4: named in the summary without a submission number

## Most influential descendants
- K080167: Acs 180 and Advia Centaur FT4 Immunoassays (2008), 2 descendants of its own
- K083373: Immulite 2000 Free T4 (2009), 1 descendant of its own
- K182423: Maglumi 2000 FT4 (2018), 0 descendants of its own
- K160647: IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 (2016), 0 descendants of its own
- K132249: Advia Centaur FT4, Advia Centaur T4 (2013), 0 descendants of its own

## Recalls of this device
- Jan 10, 2017 · Class II · Z-1254-2017: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT System
- Jan 10, 2017 · Class II · Z-1256-2017: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT System
- Jan 10, 2017 · Class II · Z-1255-2017: Siemens Healthcare Diagnostics has confirmed a negative bias for ADVIA Centaur FT4 when used with Calibrator A kit lots ending in 90 on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur XPT System
- Jun 28, 2013 · Class III · Z-1970-2013: Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay.

## Indications for use
For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.

Source page: https://510kreport.com/device/K961510
Methodology: https://510kreport.com/methodology