510(k) · Cleared
ClearedAbbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (Assayed) and Abbott Estradiol Calibrator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Aug 18, 2004 after a 57-day review. The FDA summary names no predicate by number.
- Decided
- Aug 18, 2004
- Review
- 57 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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 JJX? 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?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Abbott ARCHITECT® Estradiol Controls (LN 6C22) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations 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®…
Read the full statement (464 words)
Abbott ARCHITECT® Estradiol Controls (LN 6C22) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations 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® Estradiol Controls (LN 2K25) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations 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 Controls are devices intended for use in the AxSYM® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations 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 FSH Controls are devices intended for use in the ARCHITECT, AxSYM, and lMx FSH assay test systems to estimate test precision and to detect systematic analytical deviations 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 disorders
Abbott ARCHITECT® LH Controls are devices intended for use in the ARCHITECT LH assay test system to estimate test precision and to detect systematic analytical deviations 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.
Abbott ARCHITECT® Prolactin Controls are devices intended for use in the ARCHITECT Prolactin assay test system to estimate test precision and to detect systematic analytical deviations 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.
Abbott ARCHITECT® Progesterone Controls are devices intended for use in the ARCHITECT® Progesterone assay test system to estimate test precision and to detect systematic analytical deviations 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.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041687: Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (Assayed) and Abbott Estradiol Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041687
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026