# K032458: Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott

- Pathway: 510(k) (Abbreviated)
- Applicant: Abbott Laboratories
- Decided: Oct 6, 2003 after 56 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890135 (1989). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951629: Imx Estradiol, Abbott Laboratories (1995) Summary page 2.
- K890135: Imx Follicle Stimulating Hormone (FSH), Abbott Laboratories (1989) Summary page 2.
- K935611: Axsym Luteinizing Hormone (LH), Abbott Laboratories (1994) Summary page 2.
- K955025: Axsym Progesterone, Abbott Laboratories (1996) Summary page 3.
- K896162: Abbott Imx Prolactin, Abbott Laboratories (1990) Summary page 3.
- K934517: Axsym Total T3, Abbott Laboratories (1994) Summary page 3.

## Most influential descendants
- K111023: Abbott Architect LH Calibrators (2011), 1 descendant of its own
- K163521: Lumipulse G LH Calibrators (2017), 0 descendants of its own

## Recalls of this device
- Sep 7, 2006 · Not classified · Z-0025-2007: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient resu
- Sep 7, 2006 · Not classified · Z-0024-2007: Following a customer complaint, Abbott found an atypical stability profile for the lot of the calibrators listed in this recall. The investigation to date has shown that both controls and patient resu

## Indications for use
Abbott ARCHITECT Estradiol Calibrators are devices intended for use in the ARCHITECT Estradiol assay test system to establish points of reference that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy. Abbott AxSYM Estradiol Standard Calibrators and AxSYM Estradiol Master Calibrators are devices intended for use in the AxSYM Estradiol assay test system to establish points of reference that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy. Abbott ARCHITECT FSH Calibrators are devices intended for use in the ARCHITECT FSH assay test system to establish points of reference that are used in the quantitative determination of follicle-stimulating hormone (FSH) in human specimens. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal discorders ARCHITECT LH Calibrators are devices intended for use in the ARCHITECT LH assay test system to establish points of reference that are used in the quantitative determination of luteinizing hormone (LH) in human specimens. LH measurements are used in the diagnosis and treatment of gonadal function. ARCHITECT Progesterone Calibrators are devices intended for use in the ARCHITECT Progesterone assay test system to establish points of reference that are used in the quantitative determination of progesterone in human specimens. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta. ARCHITECT Prolactin Calibrators are devices intended for use in the ARCHITECT Prolactin assay test system to establish points of reference that are used in the quantitative determination of prolactin in human specimens. Prolactin measurements are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain AxSYM Total T3 Standard Calibrators and AxSYM Total T3 Master Calibrators are devices intended for use in the AxSYM Total T3 assay test system to establish points of reference that are used in the quantitative determination of total T3 in human specimens. Total T3 measurements are used in the diagnosis and treatment of thyroid disease.

Source page: https://510kreport.com/device/K032458
Methodology: https://510kreport.com/methodology