510(k) · Cleared
Recalled · 2006Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JIT Calibrator, Secondary
Cleared on Oct 6, 2003 as substantially equivalent to K951629 (Abbott Laboratories, 1995) and 5 other predicates after a 56-day review. Its family tree reaches back 1 generation to 1989. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 6, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 1 generation to K890135 (1989). 6 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890135 Imx Follicle Stimulating Hormone (FSH)Abbott Laboratories · 1989
- This deviceK032458 Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol…Abbott Laboratories · 2003
- Descendant · cites it directly · 1 of its ownK111023 Abbott Architect LH CalibratorsAbbott Laboratories · 2011
- Descendant · 2 generations on · 0 of its ownK163521 Lumipulse G LH CalibratorsFujirebio Diagnostics,Inc. · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890135 | Imx Follicle Stimulating Hormone (FSH) | Abbott Laboratories | 1989 | — |
| 0 (this device) | K032458 | Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator… | Abbott Laboratories | 2003 | — |
| +1 | K111023 | Abbott Architect LH Calibrators | Abbott Laboratories | 2011 | — |
| +2 | K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
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 JIT? 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
What was it cleared against? (6)
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 | Decided |
|---|---|---|---|
| * | K951629 | Imx EstradiolSummary page 2…ECT Estradiol IMx Estradiol Calibrators Both are calibrators intended to establish e IMx Estadiol Calibrators contain Calibrators (K95 1629) points of reference. 6 levels (0, 50,250,750, 1500,… | 1995 |
| * | K890135 | Imx Follicle Stimulating Hormone (FSH)Summary page 2…ARCHITECT FSH Abbott FSH Calibrators Both are calibrators intended to establish ARCHITECT FSH Calibrators Calibrators (K890135) points of reference. contain 2 levels (0, 100 mIU/mL)… | 1989 |
| * | K935611 | Axsym Luteinizing Hormone (LH)Summary page 2…LH AxSYM LH Standard Both are calibrators intended to establish ARCHITECT LH Calibrators Xibrators Calibrators (K935611) points of reference. contain 2 levels (2, 100 mIU/mL)… | 1994 |
| * | K955025 | Axsym ProgesteroneSummary page 3…erone AxSYM Progesterone Standard 0 Both are calibrators intended to establish 0 The ARCHITECT Progesterone Calibrators Calibrators (K955025) points of reference. Calibrators contain 2 levels (0.7,… | 1996 |
| * | K896162 | Abbott Imx ProlactinSummary page 3…CHITECT Prolactin Abbott Prolactin Calibrators 0 Both are calibrators intended to establish 0 The ARCHITECT Prolactin Calibrators (K896162) points of reference. Calibrators contain 2 levels (5,… | 1990 |
| * | K934517 | Axsym Total T3Summary page 3…Standard AxSYM Total T3 Standard 0 Both are calibrators intended to establish AxSYM Total T3 Standard Calibrators (LN 7A52-02) Calibrators (K934517) points of reference. Calibrators LN 7A52-02 and… | 1994 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111023 | Abbott Architect LH Calibrators | 2011 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 7, 2006 | Not classified | Z-0025-2007 | Other | 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 results have shifted upwards over time… |
| Sep 7, 2006 | Not classified | Z-0024-2007 | Other | 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 results have shifted upwards over time… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 6 ancestors has a recall.
- Of its descendants, K111023 (Abbott Laboratories, 2011) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (371 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032458 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032458: Abbott Architect Estradiol Calibrators; Abbott Imx Estradiol Calibrator; Abbott Imx Estradiol Mode 1 Calibrator; Abbott.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032458
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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