FDA product code LPS: Urinary Homocystine (Nonquantitative) Test System
LPS is the FDA product code for urinary homocystine (nonquantitative) test system. It is a Class II device, regulated under 21 CFR 862.1377 and reviewed by the Clinical Chemistry panel. FDA has cleared 29 510(k) submissions under LPS, from 19 different applicants. The average 510(k) review took 109 days (median 92). FDA has posted 18 recalls for LPS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Urinary Homocystine (Nonquantitative) Test System |
| Device class | Class II |
| Regulation | 21 CFR 862.1377 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LPS clearance
Top LPS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diazyme Laboratories | 4 | 2012-07-31 |
| Axis-Shield Diagnostics, Ltd. | 3 | 2012-05-07 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2013-05-15 |
| Anticancer, Inc. | 2 | 2008-10-10 |
| Dade Behring, Inc. | 2 | 2006-12-28 |
14 more applicants have LPS clearances. See the full list in Caduvo.
Most recent LPS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123930 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS HCY 2 REAGENT, CALIBRATOR KIT 27, HCY 2 PERFORMANCE VERIFIERS I, II AND III | 2013-05-15 | 146 |
| K121053 | Diazyme Laboratories | DIAZYME HOMOCYSTEINE POC TEST KIT | 2012-07-31 | 116 |
| K121533 | Tosoh Bioscience, Inc. | ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET | 2012-06-15 | 22 |
| K113793 | Roche | HOMOCYSTEINE TEST | 2012-06-05 | 165 |
| K112790 | Axis-Shield Diagnostics, Ltd. | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | 2012-05-07 | 224 |
Recalls for LPS devices
18 product recalls in 16 recall events; 1 initiated in the last five years and 4 still open. Most recent: 2024-10-17.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 4 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code LPS?
LPS is the FDA product code for urinary homocystine (nonquantitative) test system. It is a Class II device, regulated under 21 CFR 862.1377 and reviewed by the Clinical Chemistry panel.
What device class is LPS?
Class II, regulation 21 CFR 862.1377. Typical premarket route: 510(k).
How long does a 510(k) take for product code LPS?
Across 29 cleared submissions the average was 109 days from receipt to decision (median 92).
Which companies have the most LPS clearances?
Diazyme Laboratories (4); Axis-Shield Diagnostics, Ltd. (3); Ortho-Clinical Diagnostics, Inc. (2); Anticancer, Inc. (2); Dade Behring, Inc. (2).
Have LPS devices been recalled?
Yes: 18 product recalls across 16 recall events; the most recent began 2024-10-17.
Next steps
- Run an FDA pathway report with predicate devices for product code LPS
- Run a recall and safety report across every LPS manufacturer
- Watch product code LPS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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