510(k) · Cleared
ClearedImmunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immunalysis Corporation · QBK Meprobamate Test System
Cleared on Nov 15, 2019 as substantially equivalent to DEN170010 (Lin-Zhi International, Inc., 2018) after a 269-day review. Its family tree reaches back 1 generation to 2018.
- Decided
- Nov 15, 2019
- Review
- 269 days
- Class
- Class II
- Product code
- QBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170010 (2018). No later device cites it as a predicate yet.
- Root · 1 generation backDEN170010 LZI Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassayLin-Zhi International, Inc. · 2018
- This deviceK190397 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIAImmunalysis Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay | Lin-Zhi International, Inc. | 2018 | — |
| 0 (this device) | K190397 | Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA | Immunalysis Corporation | 2019 | — |
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 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
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 |
|---|---|---|---|
| * | DEN170010 | LZI Carisoprodol Metabolite (Meprobamate) Enzyme ImmunoassaySummary page 4…rodol Metabolite (Meprobamate) Enzyme Immunoassay, Meprobamate Drugs of Abuse Calibrators and Controls [DEN170010] D. DEVICE DESCRIPTION The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a sensitive in vitro diagnostic test… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All QBK devicesQBK Meprobamate Test System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogeneous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate, at a cutoff of 280 ng/mL in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only. The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA provides only a preliminary…
Read the full statement (125 words)
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogeneous enzyme immunoassay for the qualitative analysis of carisoprodol metabolite, Meprobamate, at a cutoff of 280 ng/mL in human urine. The assay is intended for use in laboratories with automated clinical chemistry analyzers. This in vitro diagnostic device is for prescription use only.
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Tandem Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190397 · printed Nov 3, 2026
Cite this page
510(k) Report. “K190397: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K190397
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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