510(k) · Cleared
Recalled · Class II · 2017N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LPS Urinary Homocystine (Nonquantitative) Test System
Cleared on Mar 29, 2006 as substantially equivalent to K992858 (Abbott Laboratories, 1999) after a 177-day review. Its family tree reaches back 1 generation to 1999. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 29, 2006
- Review
- 177 days
- Class
- Class II
- Product code
- LPS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992858 (1999). 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK992858 Abbott Axsym HomocysteineAbbott Laboratories · 1999 · Recalled
- This deviceK052788 N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/HDade Behring, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK063206 Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator…Dade Behring, Inc. · 2006 · Recalled
- Descendant · cites it directly · 0 of its ownK110874 Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin…Siemens Healthcare Diagnostics, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK083463 Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1…Siemens Healthcare Diagnostics · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK062105 Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007
Most influential descendants
Showing 4 of 4 · See all- K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc. · 2006 · cites it directly1descendant
- K110874Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin CalibratorSiemens Healthcare Diagnostics, Inc. · 2012 · cites it directly0descendants
- K083463Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension…Siemens Healthcare Diagnostics · 2009 · cites it directly0descendants
- K062105Diazyme Creatinine Liquid Reagents AssayDiazyme Laboratories · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992858 | Abbott Axsym Homocysteine | Abbott Laboratories | 1999 | 1 |
| 0 (this device) | K052788 | N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H | Dade Behring, Inc. | 2006 | — |
| +1 | K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1… | Dade Behring, Inc. | 2006 | 3 |
| +1 | K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator | Siemens Healthcare Diagnostics, Inc. | 2012 | — |
| +1 | K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator… | Siemens Healthcare Diagnostics | 2009 | 4 |
| +2 | K062105 | Diazyme Creatinine Liquid Reagents Assay | Diazyme Laboratories | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 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 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 |
|---|---|---|---|
| * | K992858 | Abbott Axsym HomocysteineSummary page 1…hemistry (75) Product Code: LPS; JIT; JJX 3. Identification of the Legally Marketed Device: Abbott IMx Homocysteine Assay - K992858 4. Device Description: Bound homocysteine in the sample is reduced to free homocysteine by the action of… | 1999 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063206 | Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control… | 2006 | 1 |
| K110874 | Advia Chemistry Reagents, and Advia Chemistry B2-Microglobulin Calibrator | 2012 | 0 |
| K083463 | Dimension Vista Beta 2 Microglobulin, Dimension Vista Protein 1 Calibrator, Dimension… | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2017 | Class II | Z-0191-2018 | Nonconforming Material/Component | Siemens Healthcare Diagnostics has confirmed a negative bias of approximately -20% for results obtained with N Antiserum to Human Ceruloplasmin when calibrating Ceruloplasmin with various lots of N Protein Standard SL. N/T Protein… |
| Jan 11, 2017 | Class II | Z-1227-2017 | Nonconforming Material/Component | The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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.
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?
N Latex HCY: In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BNW II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. N Protein Standard SL: Esthblishment of reference curves for the determination of IgG…
Read the full statement (174 words)
N Latex HCY:
In vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry on the BNW II and BN ProSpec® Systems. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.
N Protein Standard SL:
Esthblishment of reference curves for the determination of IgG, IgG1 ,, IgA, IgM, IgE, C3c, C4, transferrin, albumin, ct1-antitrypsin, cX2-macroglobulin, haptoglobin, a,-acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, soluble transferrin receptor, ferritin, 32-microglobulin, total protein and homocysteine by immunonephelometry with BNTM Systems.
N/T Protein Control SULL, M and H:
N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN TM Systems: IgG, IgG1 ,, IgA, IgM, C3c, C4, transferrin, albumin, al-antitrypsin, ca2 -macroglobulin, haptoglobin, a1 -acid glycoprotein, prealbumin, hemopexin, ceruloplasmin, RbP, Ig/L-chain lambda & kappa, 152-microglobulin, soluble transferrin receptor, ferritin, IgE, total protein and homocysteine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052788: N Latex Hcy, N Protein Standard SL, N/T Protein Control L/M/H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052788
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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