510(k) · Cleared
Recalled · Class II · 2018ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tosoh Bioscience, Inc. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Jun 15, 2012 as substantially equivalent to K003597 (Diagnostic Products Corp., 2001) after a 22-day review. Its family tree reaches back 1 generation to 2001. It has been recalled 2 times.
- Decided
- Jun 15, 2012
- Review
- 22 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003597 (2001). No later device cites it as a predicate yet.
- Root · 1 generation backK003597 Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model…Diagnostic Products Corp. · 2001
- This deviceK121533 ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set…Tosoh Bioscience, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003597 | Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2 | Diagnostic Products Corp. | 2001 | — |
| 0 (this device) | K121533 | ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack… | Tosoh Bioscience, Inc. | 2012 | — |
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 LPS? 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? (1)
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 |
|---|---|---|---|
| * | K003597 | Immulite Homocysteine Model LKHO1 / Immulite 2000 Homocysteine Model L2KHO2Summary page 1…Class 1,Reserved JJx Clinical Chemistry 21 CFR 862.1660 5. Predicate Device: k 003597 Siemens IMMULITE 2000 Homocysteine Immunoassay… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2018 | Class II | Z-0675-2019 | Device Design | |
| Jun 5, 2018 | Class III | Z-2827-2018 | Error in labeling | Distribution of unapproved product labeling |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All LPS devicesLPS Urinary Homocystine (Nonquantitative) Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · LPS
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LPS
141in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPS
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPS
1in 2024
MAUDE reports naming product code LPS, 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 | 2 | — | 1 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 0 |
| 2012 | 4 | 141 | 1 | 0 |
| 2013 | 1 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 8 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 4 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Reagents:
ST AlA-PACK Homocysteine is designed for INVITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDTA plasma using a Tosoh AlA System Analyzer. Homocysteine. measurements are used inthe diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.
Calibrators:
ST AlA-PACK Homocysteine Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST Alp PACK Homocysteine assay using a Tosoh AlA System Analyzer.
Controls:
The AlA-PACK Homocysteine Control Set is intended for INVITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AlA-PACK Homocysteine Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121533 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121533: ST Aia-Pack Homocysteine; ST Aia-Pack Homocysteine Calibrator Set; Aia-Pack Homocysteine Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121533
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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