(523 days)
Not Found
No
The summary describes a standard enzyme immunoassay for drug detection and does not mention any AI or ML components in its operation or analysis.
No.
This device is for in vitro diagnostic use, specifically for analyzing tapentadol in human urine. It provides preliminary analytical test results and is not intended for direct treatment or therapy.
Yes.
The document explicitly states "This in vitro diagnostic device is for prescription use only" in both the "Intended Use / Indications for Use" and "Device Description" sections.
No
The device is an in vitro diagnostic assay which involves chemical reagents and is intended for use with automated clinical chemistry analyzers, indicating it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The document explicitly states "For in vitro diagnostic use" and "This in vitro diagnostic device is for prescription use only" multiple times in both the "Intended Use / Indications for Use" and "Device Description" sections.
- Intended Use: The intended use is for the analysis of tapentadol in human urine, which is a biological specimen. This analysis is performed in vitro (outside of the body).
- Laboratory Use: The device is intended for use in laboratories, which is a typical setting for IVD testing.
- Qualitative and Semi-Quantitative Analysis: The assay performs qualitative and semi-quantitative analysis of a substance in a biological sample, a common function of IVDs.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use.
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol 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 test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
Product codes (comma separated list FDA assigned to the subject device)
DJG
Device Description
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol 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 test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
Tapentadol is a centrally acting analgesic approved by the FDA in 2008 to treat moderate to severe pain in adults. It is a u-opioid receptor agonist and is classified as a Schedule II controlled substance. The therapeutic doses of tapentadol are generally between 50 and 600 mg/ day (the range specified by the package insert)} with a median of 200 mg/day. About 99% of ingested tapentadol undergoes glucuronide conjugation (55%) and sulfate conjugation (15%) before excretion into the urine233. Wu et a14. described urine concentrations of tapentadol and its metabolites in 736 samples. The parent drug and all three metabolites were detected together in 79.9% of positive specimens (n = 586); the parent drug was detected together with glucuronide conjugate in 7.1% of positive samples. Parent drug was detected without metabolites in 49 samples. The median concentration observed for tapentadol was 3,104 ng/mL, and the concentrations of tapentadol exceeding 5,000 ng/mL were found in 37.5% of positive samples.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study:
- Study Type: Precision study
- Sample Size: 80 replicates (20 days x 2 runs x 2 replicates per panel member) for each of 9 panel members, total of 80 replicates per panel member. Tested on 3 lots of reagent.
- Key Results:
- All sample concentrations ranging from -100% to -25% of the cutoff were negative.
- All sample concentrations ranging from +25% to +100% of cutoff were positive for both qualitative and semi-quantitative interpretations.
- The %CV of the semi-quantitative results ranged from 3.6 to 9.7 for all lots tested.
- The study established the repeatability of the assay.
Specificity and Cross-Reactivity:
- Study Type: Specificity and Cross-Reactivity
- Key Results:
- All sample compounds tested were negative by both the qualitative and semi-quantitative interpretations except for N-desmethyl tapentadol glucuronide.
- The % of cross-reactivity of the semi-quantitative results was
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 9, 2022
Immunalysis Corporation Elina Arroyo Manager Regulatory Affairs 829 Towne Center Drive Pomona, California 91767
Re: K203527
Trade/Device Name: Immunalysis Tapentadol Urine HEIA™ Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: February 10, 2022 Received: February 11, 2022
Dear Elina Arroyo:
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.
1
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 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 (QS) 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 medical devices and radiation-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. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K203527
Device Name Immunalysis Tapentadol Urine HEIA™
Indications for Use (Describe)
For in vitro diagnostic use.
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol 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 test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
| Type of Use (Select one or both, as applicable) |
|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(K) SUMMARY
510(K) NUMBER: K203527
A. GENERAL INFORMATION
| Applicant Name: | Immunalysis Corporation |
|---|---|
| 829 Towne Center Drive | |
| Pomona, CA 91767 | |
| Establishment # 2020952 |
| Company Contact: | Elina Arroyo |
|---|---|
| Associate Director, Regulatory Affairs | |
| 1 312-208-1514 | |
| elina.arroyo@abbott.com | |
| Date Prepared: | February 10, 2022 |
B. DEVICE IDENTIFICATION
Trade or Proprietary Names: Immunalysis Tapentadol Urine HEIA™
Common Name: Tapentadol Urine Enzyme Immunoassay
C. REGULATORY INFORMATION
| Device Classification Name: Enzyme Immunoassay, Opiates | |
|---|---|
| Product Codes: | DJG |
| Regulatory Class: | Class II |
| Classification Regulation: | 21 CFR 862.3650, Opiate Test System |
| Panel: | Toxicology (91) |
| Predicate Device: | Immunalysis Tramadol Enzyme Immunoassay [K141803] |
4
D. DEVICE DESCRIPTION
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol 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 test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
Tapentadol is a centrally acting analgesic approved by the FDA in 2008 to treat moderate to severe pain in adults. It is a u-opioid receptor agonist and is classified as a Schedule II controlled substance. The therapeutic doses of tapentadol are generally between 50 and 600 mg/ day (the range specified by the package insert)} with a median of 200 mg/day. About 99% of ingested tapentadol undergoes glucuronide conjugation (55%) and sulfate conjugation (15%) before excretion into the urine233. Wu et a14. described urine concentrations of tapentadol and its metabolites in 736 samples. The parent drug and all three metabolites were detected together in 79.9% of positive specimens (n = 586); the parent drug was detected together with glucuronide conjugate in 7.1% of positive samples. Parent drug was detected without metabolites in 49 samples. The median
1 Janssen Pharmaceuticals, Inc. https://www.nucynta.com/hcp/ir/individualized-dosing/
1 Terlinden R, Ossig J, Fliegert F, Lange C, Goehler K. Absorption, metabolism, and excretion of 14C-labeled tapentadol HCI in healthy male subjects. Eur J Drug Metab Pharmacokinetics 2007; 32:163-169.
3 DePriest AZ, Puet BL, Holt AC, Roberts A, Cone EJ. Metabolism and disposition opioids: A Review. Forensic Sci Rev. 2015 Jul;27(2):115-45. Review.
4 Wu F, Slawson MH, Johnson-Davis KL. Metabolic patterns of fentanyl, meperidine, methylphenidate, tapentadol and tramadol observed in urine, serum or plasma. J Anal Toxicol. 2017;41(4):289-299
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concentration observed for tapentadol was 3,104 ng/mL, and the concentrations of tapentadol exceeding 5,000 ng/mL were found in 37.5% of positive samples.
E. INTENDED USE
For in vitro diagnostic use.
The Immunalysis Tapentadol Urine HEIA™ is a homogeneous enzyme immunoassay with a cutoff of 200 ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of tapentadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against tapentadol. This in vitro diagnostic device is for prescription use only.
The Immunalysis Tapentadol 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 test result, particularly when preliminary positive results are used.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation using a confirmatory method such as Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
F. COMPARISON WITH PREDICATE
Immunalysis Tramadol Enzyme Immunoassay was selected as the predicate because both Tapentadol and Tramadol are in the opioid family and share identical characteristics except for the analyte being detected. The following Table 5-1 includes a summary of the technological characteristics.
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| Attribute | Candidate Device
Immunalysis Tapentadol Urine
HEIATM | Predicate Device
Immunalysis Tramadol Enzyme
Immunoassay [K141803] |
|--------------------------------------|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | Identical | For the qualitative and semi-
quantitative analysis of an opioid in
human urine with automated
clinical chemistry analyzers. |
| Test Principle | Identical | Homogeneous enzyme
immunoassay |
| User
Environment | Identical | For use in laboratories |
| Sample Matrix | Identical | Human urine |
| Mass
Spectrometry
Confirmation | Identical | Required for preliminary positive
analytical results |
| Reagent Storage | Identical | 2-8°C until expiration date |
| Assay Materials | Identical | Two analytical reagents:
antibody/substrate reagent and
enzyme labeled conjugate reagent |
| Assay Cutoff
Level | Identical | 200 ng/mL |
| Instrumentation | Identical | Automated Clinical chemistry
analyzer |
| Differences | | |
| Antibody | Recombinant FAB antibody to
Tapentadol | Goat Polyclonal Antibody to
Tramadol |
| Calibrator | Tapentadol | Tramadol |
Table 5-1 Comparison to Predicate Device
G. PERFORMANCE CHARACTERISTICS
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Tapentadol Urine HEIA™ to the predicate device. Assay performance was established using the Beckman Coulter AU480 chemistry analyzer.
1. Precision
Precision study was performed over 20 days, two runs per day in duplicates (20 x 2 x 2 replicates per panel member) for a total of 80 replicates (N=80) on 3 lots of reagent. Nine panel members were made using Drug free negative urine as the base sample and 8 panel members were spiked to concentrations of assay cutoff and ±25%, ±50%, ±75%, ±100%
7
of the cutoff (200 ng/mL). The concentrations used for spiking were confirmed by mass spectrometry (LC-MS/MS). The data demonstrates all sample concentration ranging from -100% to -25% of the cutoff were negative and all sample concentrations ranging from +25% to +100% of cutoff were positive for both qualitative and semi-quantitative interpretations. The %CV of the semi-quantitative results ranged from 3.6 to 9.7 for all lots tested. The study established the repeatability of the assay. Test results in qualitative and semi-quantitative modes for a representative lot are presented in Tables 2 to 7.
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 50 | -75% | 80 | 80 Negative |
| 100 | -50% | 80 | 80 Negative |
| 150 | -25% | 80 | 80 Negative |
| 200 | Cutoff | 80 | 41 Neg / 39 Pos |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
Table 2. Precision – Qualitative Lot#1
Table 3. Precision - Qualitative Lot#2
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 50 | -75% | 80 | 80 Negative |
| 100 | -50% | 80 | 80 Negative |
| 150 | -25% | 80 | 80 Negative |
| 200 | Cutoff | 80 | 35 Neg / 45 Pos |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
8
| Concentration
| (ng/mL) | % of Cutoff | # of Determinations | Result |
|---|---|---|---|
| 0 | -100% | 80 | 80 Negative |
| 50 | -75% | 80 | 80 Negative |
| 100 | -50% | 80 | 80 Negative |
| 150 | -25% | 80 | 80 Negative |
| 200 | Cutoff | 80 | 42 Neg / 38 Pos |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
Table 4. Precision – Qualitative Lot#3
Table 5. Precision - Semi-Quantitative Lot#1
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|----------------|
| 0 | -100% | 80 | -3 | 80 Negative |
| 50 | -75% | 80 | 48 | 80 Negative |
| 100 | -50% | 80 | 99 | 80 Negative |
| 150 | -25% | 80 | 161 | 80 Negative |
| 200 | Cutoff | 80 | 215 | 2 Neg / 78 Pos |
| 250 | +25% | 80 | 268 | 80 Positive |
| 300 | +50% | 80 | 304 | 80 Positive |
| 350 | +75% | 80 | 372 | 80 Positive |
| 400 | +100% | 80 | 431 | 80 Positive |
Table 6. Precision - Semi-Quantitative Lot#2
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|----------------|
| 0 | -100% | 80 | -4 | 80 Negative |
| 50 | -75% | 80 | 50 | 80 Negative |
| 100 | -50% | 80 | 100 | 80 Negative |
| 150 | -25% | 80 | 162 | 80 Negative |
| 200 | Cutoff | 80 | 213 | 8 Neg / 72 Pos |
| 250 | +25% | 80 | 263 | 80 Positive |
| 300 | +50% | 80 | 298 | 80 Positive |
| 350 | +75% | 80 | 359 | 80 Positive |
| 400 | +100% | 80 | 417 | 80 Positive |
9
| Concentration
(ng/mL) | % of
Cutoff | # of
Determinations | Mean Conc.
(ng/mL) | Result |
|--------------------------|----------------|------------------------|-----------------------|----------------|
| 0 | -100% | 80 | -3 | 80 Negative |
| 50 | -75% | 80 | 49 | 80 Negative |
| 100 | -50% | 80 | 102 | 80 Negative |
| 150 | -25% | 80 | 162 | 80 Negative |
| 200 | Cutoff | 80 | 215 | 7 Neg / 73 Pos |
| 250 | +25% | 80 | 266 | 80 Positive |
| 300 | +50% | 80 | 303 | 80 Positive |
| 350 | +75% | 80 | 369 | 80 Positive |
| 400 | +100% | 80 | 422 | 80 Positive |
Table 7. Precision - Semi-Quantitative Lot#3
2. Specificity and Cross-Reactivity
Structurally and functionally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoff. The data demonstrates all sample compounds tested were negative by both the qualitative and semi-quantitative interpretations except for N-desmethyl tapentadol glucuronide. The % of cross- reactivity of the semi-quantitative results was 300 ng/mL
(greater
than +50%
cutoff) | Agreement (%) |
| Qual. | Positive | 0 | 0 | 14 | 81 | 100% (95/95) |
| Qual. | Negative | 46 | 19 | 0 | 0 | 100% (65/65) |
| Semi-
Quant. | Positive | 0 | 0 | 14 | 81 | 100% (95/95) |
| Semi-
Quant. | Negative | 46 | 19 | 0 | 0 | 100% (65/65) |
Table 15. Method Comparison Results by Concentration Range
Table 16. Method Comparison Results Compared to LC-MS/MS
| Immunalysis Tapentadol Urine HEIA™ | LC-MS/MS | ||
|---|---|---|---|
| (+) | (-) | ||
| Qualitative | (+) | 95 | 0 |
| (-) | 0 | 65 | |
| Semi-Quantitative | (+) | 95 | 0 |
| (-) | 0 | 65 |
H. CONCLUSION
The information provided in this pre-market notification demonstrates that the Immunalysis Tapentadol Urine HEIA™ is substantially equivalent to the legally marketed predicate device.