# K983212: Abbott Architect Testosterone

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 18, 1998 after 65 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Chiron Diagnostics ACS:180® Testosterone assay: named in the summary without a submission number

## Most influential descendants
- K170317: Alinity i Total ß-hCG Reagent Kit, Alinity i System (2017), 1 descendant of its own
- K230790: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (2023), 0 descendants of its own

## Recalls of this device
- Sep 29, 2021 · Class II · Z-0271-2022: Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to ove
- Sep 29, 2021 · Class II · Z-0272-2022: Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to ove
- Sep 11, 2009 · Not classified · Z-1316-2010: ARCHITECT System Software v5.00 and v5.10 are incompatible with ARCHITECT LLS Board. Software patch re-establishes correct parameters.
- Jul 17, 2009 · Not classified · Z-0132-2010: Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground str
- Apr 30, 2007 · Not classified · Z-0950-2007: One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not 
- Apr 30, 2007 · Not classified · Z-0951-2007: One or more of four software issues : 1) calculation error for Architect cSystem assays using the Spline math model. 2) The system configuration option, Run controls onboard reagents by Kit, does not 
- Mar 28, 2007 · Not classified · Z-0790-2007: If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
- Mar 28, 2007 · Not classified · Z-0791-2007: If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
- Dec 12, 2006 · Not classified · Z-0415-2007: The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stoppin
- Dec 12, 2006 · Not classified · Z-0416-2007: The re-designed ARCHITECT Temperature Controller Board has been identified as being susceptible to electromagnetic interference (EMI) in the laboratory. This can cause a board reset condition, stoppin
- Mar 19, 2004 · Not classified · Z-0818-04: When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.
- Nov 17, 2003 · Not classified · Z-0262-04: Sample Identification (SID) numbers of a bar coded sample may be truncated, or shortened, after being scanned by the bar code reader (e.g. an actual SID of 123456 is shortened to 1234)
- May 8, 2002 · Not classified · Z-0172-04: If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.
- Dec 10, 2001 · Not classified · Z-1133-03: Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.

## Indications for use
Abbott ARCHITECT Testosterone is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of testosterone in human serum and plasma on the Abbott ARCHITECT i System. Measurements of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females, hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Source page: https://510kreport.com/device/K983212
Methodology: https://510kreport.com/methodology