510(k) · Cleared
ClearedAudit Microcv Homocysteine Linearity Set, Model 704M-5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aalto Scientific, Ltd. · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Dec 23, 2010 as substantially equivalent to K984071 (Bio-Rad, 1998) and 1 other predicate after a 286-day review. Its family tree reaches back 3 generations to 1991. 14 later devices descend from it.
- Decided
- Dec 23, 2010
- Review
- 286 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K910440 (1991). 6 ancestors in all. 14 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK910440 Document Reflectance II Linearity Test SetCasco Standards · 1991
- 2 generations backK023410 Validate Chem 10 Calibration Verification Test Set, Model 110Maine Standards Co. · 2003
- 1 generation backK042318 Audit Microcv General Chemistry Linearity SetAalto Scientific, Ltd. · 2004
- This deviceK100715 Audit Microcv Homocysteine Linearity Set, Model 704M-5Aalto Scientific, Ltd. · 2010
- Descendant · cites it directly · 13 of its ownK133128 Immulite 2000; HCG Calibration Verification Material, Insulin…Siemens Healthcare Diagnostics, Inc. · 2013
- Descendant · 2 generations on · 7 of its ownK140258 Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK140818 Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 2 generations on · 2 of its ownK140541 Immulite 2000: C-Peptide Calibration Verification Material, SHBG…Siemens Healthcare Diagnostics, Inc. · 2014
- Descendant · 3 generations on · 1 of its ownK141444 Immulite 2000; Cortisol Calibration Verification Material, Folic…Siemens Healthcare Diagnostics, Inc. · 2014
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K133128Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2013 · cites it directly13descendants
- K140258Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on7descendants
- K140818Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on3descendants
- K140541Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 2 generations on2descendants
- K141444Immulite 2000; Cortisol Calibration Verification Material, Folic Acid Calibration…Siemens Healthcare Diagnostics, Inc. · 2014 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910440 | Document Reflectance II Linearity Test Set | Casco Standards | 1991 | — |
| −2 | K023410 | Validate Chem 10 Calibration Verification Test Set, Model 110 | Maine Standards Co. | 2003 | — |
| −1 | K042318 | Audit Microcv General Chemistry Linearity Set | Aalto Scientific, Ltd. | 2004 | — |
| 0 (this device) | K100715 | Audit Microcv Homocysteine Linearity Set, Model 704M-5 | Aalto Scientific, Ltd. | 2010 | — |
| +1 | K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration… | Siemens Healthcare Diagnostics, Inc. | 2013 | — |
| +2 | K140258 | Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K140818 | Immulite: 2000 Free T4 Calibration Verification Material, 2000 Igf-I… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +2 | K140541 | Immulite 2000: C-Peptide Calibration Verification Material, SHBG Calibration… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
| +3 | K141444 | Immulite 2000; Cortisol Calibration Verification Material, Folic Acid… | Siemens Healthcare Diagnostics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 8 | 0 |
| 2015 | 5 | 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 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? (2)
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 |
|---|---|---|---|
| * | K984071 | Liquichek Homocysteine Control, Cat #644Summary page 1…me: Liquichek Homocysteine Control Bio-Rad Laboratories, Irvine, California K984071 Audit MicroCV General Chemistry Linearity Set Aalto… | 1998 |
| * | K042318 | Audit Microcv General Chemistry Linearity SetSummary page 1…Audit MicroCV General Chemistry Linearity Set Aalto Scientific, Ltd., Carlsbad, California K042318 Page 3 of 29 AAlk StiIIMf, It… | 2004 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133128 | Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification… | 2013 | 13 |
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.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K133128 (Siemens Healthcare Diagnostics, Inc., 2013) has gone furthest, with 13 descendants of its own.
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. 2010, this device’s year, is highlighted.
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?
The AuditTM MieroCVTM Homrocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Honiocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. it is intended to simulate human patient serum samples for purpose of detenmining linearity, calibration verification and verification of reportable range for Hoiiocysteine. The product is…
Read the full statement (107 words)
The AuditTM MieroCVTM Homrocysteine Linearity Set is assayed quality control material consisting of five levels human based serum. Each level contains Honiocysteine analyte. The five levels demonstrate a linear relationship to each other for Homocysteine analyte. it is intended to simulate human patient serum samples for purpose of detenmining linearity, calibration verification and verification of reportable range for Hoiiocysteine. The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling. The AuditTIM MicroCVTM Homocysteine Linearity Set should not be used for calibration or standardization of the Homocysteine assay. The AuditTM MicroCVTM1 Homocysteine Linearity Set is "For In Vitro Diagnostic Use Only".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100715: Audit Microcv Homocysteine Linearity Set, Model 704M-5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100715
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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