De Novo · Granted
GrantedLZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · QBK Meprobamate Test System
Granted on Apr 20, 2018 as a new device type through De Novo after a 423-day review. 1 later device descends from it.
- Decided
- Apr 20, 2018
- Review
- 423 days
- Class
- Class II
- Product code
- QBK
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN170010 LZI Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayLin-Zhi International, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK190397 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAImmunalysis Corporation · 2019
Most influential descendants
Showing 1 of 1 · See all- K190397Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAImmunalysis Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Lin-Zhi International, Inc. | 2018 | — |
| +1 | K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Immunalysis Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA De Novo 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 QBK? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | 2019 | 0 |
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?
- Of its descendants, K190397 (Immunalysis Corporation, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QBK devicesQBK Meprobamate Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBK
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · QBK
Too few QBK 510(k)s in any year since 2007 to give a median.
Recalls per year · QBK
No recall names QBK since 2007.
Adverse event reports per year · QBK
No MAUDE report names QBK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate…
Read the full statement (137 words)
The LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of carisoprodol metabolite (meprobamate) in human urine at a cutoff value of 100 ng/mL when calibrated against meprobamate. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for verification by a confirmatory method such as GC/MS, LC/MS or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative chemical confirmatory method (e.g., gas or liquid chromatography and mass spectrometry) must be used to obtain a confirmed analytical result. Clinical consideration and professional judgment must be exercised with any drug of abuse test, particularly when the preliminary test result is positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN170010 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN170010: LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN170010
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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