(269 days)
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No
The device description and performance studies detail a standard homogeneous enzyme immunoassay (HEIA) for drug detection, which relies on chemical reactions and spectrophotometric analysis, not AI/ML algorithms. There are no mentions of AI, ML, or related concepts in the summary.
No
This device is an in vitro diagnostic (IVD) device used for qualitative analysis of a drug metabolite in human urine, providing preliminary test results for diagnostic purposes, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is for prescription use only." This confirms its diagnostic purpose.
No
The device is an in vitro diagnostic test that utilizes reagents and is intended for use with automated clinical chemistry analyzers, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "This in vitro diagnostic device is for prescription use only."
Furthermore, the "Device Description" section also refers to it as a "sensitive in vitro diagnostic test".
The entire description and performance studies are consistent with the characteristics of an in vitro diagnostic device used for analyzing biological samples (human urine) to provide information about a patient's health status (presence of a drug metabolite).
N/A
Intended Use / Indications for Use
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 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.
Product codes
QBK
Device Description
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a sensitive in vitro diagnostic test intended for use in laboratories for the qualitative analysis of Meprobamate at a cutoff of 280 ng/mL in human urine with automated clinical chemistry analyzers.
Carisoprodol (N-isopropylmeprobamate, Soma, ingredient of Soma Compound, Somadril®) is a carbamate derivative first synthesized in 1959 and used clinically as a muscle relaxant and sedative. Carisoprodol is known to be metabolized to meprobamate and hydroxyl-meprobamate.
The assay is based on the competition of carisoprodol labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free Meprobamate in the urine sample for the fixed amount of sheep anti-carisoprodol antibody binding sites. In the absence of the free Meprobamate in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories with automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Precision/Cutoff Characterization - Meprobamate:
- Study Type: Precision/Cutoff Characterization
- Sample Size: 80 determinations per concentration for each of 3 lots (total 240 determinations per concentration)
- Data Source: Drug-free urine spiked with meprobamate.
- Annotation Protocol: Spiked concentrations confirmed by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
- Key Results: The study verified that the cutoff (280 ng/mL) serves as a boundary between negative and positive interpretation.
-
Specificity and Cross-Reactivity:
- Study Type: Cross-reactivity
- Sample Size: Not explicitly stated, but various compounds were tested.
- Data Source: Drug-free urine spiked with structurally and functionally similar compounds to meprobamate.
- Key Results: Verified assay performance relative to the ability of the device to exclusively determine certain drugs in qualitative mode.
-
Interference – Meprobamate – Structurally Unrelated Compounds:
- Study Type: Interference
- Sample Size: Not explicitly stated, but various compounds were tested.
- Data Source: Drug-free negative urine containing meprobamate concentration equivalent to ±25% of the assay cutoff, with potential interfering compounds spiked in.
- Key Results: Assay performance unaffected by externally ingested compounds.
-
Interference - Endogenous Compounds and Urine Preservatives:
- Study Type: Interference
- Sample Size: Not explicitly stated, but various compounds were tested.
- Data Source: Drug-free urine containing meprobamate concentration equivalent to ±25% of the assay cutoff, with potential interferents spiked in.
- Key Results: Other than boric acid, assay performance is unaffected by other internally existing physiological conditions or urine preservatives. Boric acid showed interference.
-
Interference - pH:
- Study Type: Interference
- Sample Size: Not explicitly stated, but tested at various pH values.
- Data Source: Drug-free urine containing meprobamate at the concentration equivalent to ±25% of the carisoprodol assay cutoff, adjusted to pH 3.0, 7.0, and 11.0.
- Key Results: No positive or negative interference was observed at urine pH values 3.0, 7.0 and 11.0.
-
Interference - Specific Gravity:
- Study Type: Interference
- Sample Size: Not explicitly stated, but tested at various specific gravity values.
- Data Source: Drug-free urine containing meprobamate at the concentration equivalent to ±25% of the carisoprodol assay cutoff, adjusted to specific gravity values 1.000, 1.015, and 1.030.
- Key Results: No positive or negative interference was observed at urine specific gravity values 1.000, 1.015 and 1.030.
-
Calibration Duration:
- Study Type: Calibration Duration
- Sample Size: Not explicitly stated.
- Data Source: Drug-free negative urine spiked with carisoprodol at ±25% of the cutoff.
- Key Results: The recommended frequency of calibration is 14 days.
-
Specimen Stability (Urine):
- Study Type: Specimen Stability
- Sample Size: Not explicitly stated.
- Data Source: De-identified, unaltered clinical urine samples containing carisoprodol and/or meprobamate.
- Annotation Protocol: Tested by LC-MS/MS at each time point.
- Key Results: Urine samples containing carisoprodol and/or meprobamate are stable for up to 7 days stored at ambient temperature (up to 30°C) and up to 6 months stored at 2°C - 8°C.
-
Urine Elimination Study:
- Study Type: Urine Elimination
- Sample Size: 10 subjects
- Data Source: Self-reported single dose users of 250 mg or 350 mg of carisoprodol. Urine samples collected over time.
- Annotation Protocol: Carisoprodol and Meprobamate mass spectrometry analysis was performed for all samples.
- Key Results: The earliest time post ingestion of drug that the carisoprodol or meprobamate in the urine specimen decreased below cutoff level is 45.5 hours.
-
Method Comparison:
- Study Type: Method Comparison
- Sample Size: 167 de-identified, unaltered leftover clinical urine samples.
- Data Source: Clinical testing laboratories.
- Annotation Protocol: Analyzed by the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA and by LC-MS/MS. Cutoff of 280 ng/mL of meprobamate used for LC-MS/MS.
- Key Results: 55 specimens showed negative results by both methods, and 107 specimens showed positive results by both methods. Five false positive samples each contained carisoprodol and were not a cause for clinical concern. Agreement for positive results was 100% (107/107), and for negative results was 92% (55/60).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Method Comparison Study:
Agreement for positive results: 100% (107/107)
Agreement for negative results: 92% (55/60)
Predicate Device(s)
Lin-Zhi Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay, Meprobamate Drugs of Abuse Calibrators and Controls [DEN170010]
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3590 Meprobamate test system.
(a)
Identification. A meprobamate test system is a device intended to measure meprobamate in human specimens. Measurements obtained by this device are used to detect the presence of meprobamate to diagnose the use or overdose of meprobamate or structurally-related drug compounds (e.g., prodrugs).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) Robust data demonstrating the accuracy of the device when used in the intended specimen matrix. The accuracy data must include a comparison between the meprobamate test system results and meprobamate results that are measured on an FDA-accepted measurement method that is specific and accurate (e.g., gas or liquid chromatography combined with tandem mass spectrometry).
(ii) Robust analytical data demonstrating the performance characteristics of the device, including, but not limited to, specificity, cross-reactivity to relevant endogenous and exogenous substances, and the reproducibility of analyte detection around the cutoff(s).
(2) The intended use of the device must not include an indication for use in monitoring therapeutic drug concentrations or informing dosing adjustment decisions.
(3) Your 21 CFR 809.10 labeling must include the following:
(i) If indicated for use as a screening test to identify preliminary results for further confirmation, the intended use must state “This 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.”
(ii) A limiting statement that reads as follows: “This test should not be used to monitor therapeutic drug concentrations or to inform dosing adjustment decisions.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
November 15, 2019
Immunalysis Corporation Yang Yang Regulatory Affairs Specialist II 829 Towne Center Drive Pomona, CA 91767
Re: K190397
Trade/Device Name: Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA Regulation Number: 21 CFR 862.3590 Regulation Name: Meprobamate Test System Regulatory Class: Class II Product Code: QBK Dated: October 3, 2019 Received: October 4, 2019
Dear Yang Yang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190397
Device Name
Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA
Indications for Use (Describe)
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 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.
| Type of Use (Select one or both , as applicable) |
|---|
| ---------------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY: K190397
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation
829 Towne Center Drive
Pomona, CA 91767
Establishment # 2020952 |
|------------------|--------------------------------------------------------------------------------------------------------|
| Company Contact: | Yang Yang
Regulatory Affairs Specialist II
Phone: (909) 451-6665
Email: yyang@immunalysis.com |
| Date Prepared: | November 13, 2019 |
B. DEVICE IDENTIFICATION
| Trade or Proprietary Names: | Immunalysis Carisoprodol Metabolite / Meprobamate Urine
HEIA |
|-----------------------------|-------------------------------------------------------------------|
| Common Name: | Carisoprodol Metabolite / Meprobamate Urine Enzyme
Immunoassay |
C. REGULATORY INFORMATION
| Device Classification Name: | Meprobamate Test System |
|---|---|
| Product Codes: | QBK |
| Regulatory Class: | II |
| Classification Regulation: | 21 CFR 862.3590, Meprobamate Test System |
| Panel: | Toxicology (91) |
| Predicate Device: | Lin-Zhi Carisoprodol 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 intended for use in laboratories for the qualitative analysis of Meprobamate at a cutoff of 280 ng/mL in human urine with automated clinical chemistry analyzers.
Carisoprodol (N-isopropylmeprobamate, Soma, ingredient of Soma Compound, Somadril®) is a carbamate derivative first synthesized in 1959 and used clinically as a muscle relaxant and sedative. Carisoprodol is known to be metabolized to meprobamate and hydroxyl-meprobamate.
The assay is based on the competition of carisoprodol labeled enzyme glucose-6-phosphate
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dehydrogenase (G6PDH) and the free Meprobamate in the urine sample for the fixed amount of sheep anti-carisoprodol antibody binding sites. In the absence of the free Meprobamate in the sample, the antibody binds the drug enzyme conjugate and enzyme activity is inhibited. This creates a dose response relationship between drug concentration in the urine and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of nicotinamide adenine dinucleotide (NAD) to NADH.
E. INTENDED USE
The Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is a homogenous 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.
| Attribute | Predicate Device
Lin-Zhi Carisoprodol Metabolite
(Meprobamate) Enzyme
Immunoassay [DEN170010] | Candidate Device
Immunalysis Carisoprodol
Metabolite / Meprobamate Urine
HEIA |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | For the qualitative and semi-
quantitative determination of the
presence of carisoprodol metabolite
(meprobamate) in human urine with
automated clinical chemistry
analyzers. | For the qualitative analysis of
carisoprodol metabolite,
meprobamate, in human urine with
automated clinical chemistry
analyzers. |
| Test Principle | Homogeneous Enzyme
Immunoassay | Same |
| User Environment | For use in laboratories | Same |
| Sample Matrix | Human Urine | Same |
| Mass Spectrometry
Confirmation | Required for preliminary positive
analytical results | Same |
| Reagent Storage | 2-8°C until expiration date | Same |
| Assay Materials | 2 analytical reagents:
Antibody/Substrate Reagent and
Enzyme Labeled Conjugate | Same |
| Differences | | |
| Assay Cutoff Level | 100 ng/mL | 280 ng/mL |
F. COMPARISON WITH PREDICATE
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| Attribute | Predicate Device
Lin-Zhi Carisoprodol Metabolite
(Meprobamate) Enzyme
Immunoassay [DEN170010] | Candidate Device
Immunalysis Carisoprodol
Metabolite / Meprobamate Urine
HEIA |
|------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Antibody | Mouse monoclonal anti-
meprobamate | Polyclonal sheep antibodies to
carisoprodol |
| Calibrator | Meprobamate | Carisoprodol |
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA to the predicate device. Assay performance was established using the Olympus AU400e analyzer.
1. Precision/Cutoff Characterization - Meprobamate
Precision/Cutoff Characterization study for meprobamate was performed for ten days using three product lots with two runs per day in replicates of four on drug free urine (N=80) spiked with meprobamate to concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff. The spiked concentrations were confirmed by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. Precision test results in qualitative mode are presented in Table 9 - 11.
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 70 | -75% | 80 | 80 Negative |
| 140 | -50% | 80 | 80 Negative |
| 210 | -25% | 80 | 80 Negative |
| 280 | Cutoff | 80 | 40 Neg/40 Pos |
| 350 | +25% | 80 | 80 Positive |
| 420 | +50% | 80 | 80 Positive |
| 490 | +75% | 80 | 80 Positive |
| 560 | +100% | 80 | 80 Positive |
Table 1. Meprobamate Precision - Lot#1
| Table 2. Meprobamate Precision - Lot#2 |
|---|
| ---------------------------------------- |
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 70 | -75% | 80 | 80 Negative |
| 140 | -50% | 80 | 80 Negative |
| 210 | -25% | 80 | 80 Negative |
| 280 | Cutoff | 80 | 38 Neg/42 Pos |
| 350 | +25% | 80 | 80 Positive |
| 420 | +50% | 80 | 80 Positive |
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| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 490 | +75% | 80 | 80 Positive |
| 560 | +100% | 80 | 80 Positive |
Table 3. Meprobamate Precision - Lot#3
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 70 | -75% | 80 | 80 Negative |
| 140 | -50% | 80 | 80 Negative |
| 210 | -25% | 80 | 80 Negative |
| 280 | Cutoff | 80 | 39 Neg/41 Pos |
| 350 | +25% | 80 | 80 Positive |
| 420 | +50% | 80 | 80 Positive |
| 490 | +75% | 80 | 80 Positive |
| 560 | +100% | 80 | 80 Positive |
2. Specificity and Cross-Reactivity
Structurally and functionally similar compounds to meprobamate were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoff. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs in the qualitative mode. Cross-reactivity test results in qualitative mode are presented in Table 4.
| Table 4. Cross-Reactivity - Qualitative | ||
|---|---|---|
| -- | ----------------------------------------- | -- |
| Compound | Compound
Conc.
(ng/mL) | Result | Cross-
Reactivity (%) |
|------------------------|------------------------------|--------|--------------------------|
| Meprobamate | 280 | POS | 100% |
| Carisoprodol | 100 | POS | 280% |
| Buprenorphine | 100,000 | NEG | 420 ng/mL
(greater than
+50% cutoff) | Agreement (%) |
| Positive | 3 | 2 | 3 | 104 | 100% (107/107) |
| Negative | 51 | 4 | 0 | 0 | 92% (55/60) |
Table 9 Discrepant Samples
| Qualitative Result | Meprobamate
(ng/mL) | Carisoprodol
(ng/mL) |
|--------------------|------------------------|-------------------------|
| POS | 0 | 147 |
| POS | 0 | 148 |
| POS | 0 | 750 |
| POS | 201 | 35,156 |
| POS | 230 | 120,593 |
H. CONCLUSION
The information provided in this pre-market notification demonstrates that the Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA is substantially equivalent to the legally marketed predicate device for its intended use.