(224 days)
Not Found
No
The device description and performance studies focus on standard enzyme immunoassay technology and analytical methods, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in-vitro diagnostic assay for detecting Tramadol in human urine, not a device used for medical treatment or therapy.
Yes.
The "Intended Use / Indications for Use" section explicitly states, "This in-vitro diagnostic device is for prescription use only." It also describes its purpose as "for the qualitative and semi-quantitative analysis of Tramadol in human urine," which is a diagnostic function.
No
The device is an in-vitro diagnostic device consisting of reagents, calibrators, and controls for a laboratory assay, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in-vitro diagnostic device is for prescription use only."
- Intended Use: The device is intended for the qualitative and semi-quantitative analysis of Tramadol in human urine, which is a biological specimen. This analysis is performed in vitro (outside the body) in a laboratory setting.
- Device Description: The description details reagents, calibrators, and controls, which are typical components of IVD assays.
- Performance Studies: The document describes various performance studies (Precision, Specificity, Interference, Linearity, Method Comparison, Stability) that are standard for validating IVD devices.
- Predicate Device: The mention of a "Predicate Device" (K120761; LZI Opiate 2000 Enzyme Immunoassay; LZI Opiate 2000 Enzyme Controls; LZI Opiate 2000 Enzyme Calibrators) is a strong indicator that this device is being compared to a previously cleared IVD.
All these factors clearly indicate that the Immunalysis Tramadol Urine Enzyme Immunoassay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Immunalysis Tramadol Urine Enzyme Immunoassay:
The Immunalysis Tramadol Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/ mL. The assay is intended for use in laboratories for the qualitative analysis of Tramadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against Tramadol. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The test is not intended to differentiate between drugs of abuse and prescription use of Tramadol. There are no uniformly recognized drug levels for Tramadol in urine.
The Immunalysis Tramadol Urine Enzyne Immunoassay Kit 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 / Mass Spectroscopy (LC/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.
Immunalysis Tramadol Urine Controls:
The Immunalysis Tramadol Urine Controls are used as control materials in the Immunalysis Tramadol Urine Enzyme Immunoassay.
Immunalysis Tramadol Urine Calibrators:
The Immunalysis Tramadol Urine Calibrators are used as calibrators in the Immunalysis Tramadol Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Tramadol in urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ, LAS
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes goat antibodies to Tramadol, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjuqate reagent includes tramadol derivative labeled with qlucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The tramadol calibrator and controls consists of a single calibrator at 200ng/mL, a control set containing a LOW control at 150ng/mL and a HIGH control at 250ng/mL and a calibrator set containing a negative calibrator, a Level 1 calibrator at 100ng/mL, a Level 2 calibrator at 200ng/mL, a Level 3 calibrator at 500ng/mL and a Level 4 calibrator at 1000nq/mL.
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
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision/ Cutoff Characterization Study: Performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75% and ±100% of the cutoff. Verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result and the product performance relative to the ability of the device to produce the same value during repeated measurements.
- Specificity and Cross-Reactivity: Structurally similar compounds were spiked into drug free urine at levels that will yield a result that is equivalent to the cutoff. Verified assay performance relative to the ability of the device to exclusively determine certain drugs.
- Interference: Structurally non-similar compounds, endogenous compounds, the effect of pH and the effect of specific gravity was evaluated by spiking the potential interferent into drug free urine containing the target analyte at ±25% of the cutoff. Boric Acid caused a false negative response at the concentration tested. All other potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or an internally existing physiological condition.
- Linearity/ Recovery: A drug free urine pool was spiked with a high concentration of the target analyte as a high value specimen. Additional pools were made by serially diluting the high value specimen. Verified assay linearity in the semi-quantitative mode.
- Method Comparison: Unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed with the test device. Verified that the product performance can be verified by Mass Spectrometry.
- Stability:
a. Closed accelerated stability study on reagents, calibrators, and controls at 25°C to establish initial expiration dating of 1 year for reagents, 12 months for calibrators and controls.
b. Open/ on-board stability study on reagents to establish expiration dating when reagents are opened and stored on board the instrument at 2℃ to 8℃. Supported initial open vial expiration date of 28 days.
c. Specimen and Storage Handling study on a specimen below the cutoff near the bracketing control and a specimen above the cutoff near the bracketing control to establish specimen storage and handling stability at 2 – 8°C. Supported a 1 month specimen storage and handling recommendation at 2 - 8°C. - Calibrator and Control Traceability: All components traced to a commercially available standard solution from Cerilliant Chemicals.
- Calibrator and Control Stability: Open accelerated stability study performed at 37°C to establish initial open vial expiration dating of 6 months.
- Calibrator and Control Value Assignment: Calibrators and controls are manufactured and tested by mass spectrometry. Values assigned once Mass spectrometry results are within acceptable ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Qualitative Analysis (for 200ng/mL cutoff):
- Concentration (ng/mL) 200: 44 Negative/36 Positive out of 80 determinations
Semi-Quantitative Analysis (for 200ng/mL cutoff):
- Concentration (ng/mL) 200: 47 Negative/ 33 Positive out of 80 determinations
Specificity and Cross-Reactivity:
- Tramadol: 100.00%
- n-Desmethyl Tramadol: 44.4%
- o-Desmethyl Tramadol: 0.8%
- Venlafaxine: N.D.
- o-Desmethyl Venlafaxine: N.D.
Interference:
- Boric Acid: Caused a false negative response.
Method Comparison - Qualitative assay performance (200ng/mL cutoff) verified by LC/MS:
- Test Device (+), LC/MS Confirmation (+): 100
- Test Device (+), LC/MS Confirmation (-): 0
- Test Device (-), LC/MS Confirmation (+): 0
- Test Device (-), LC/MS Confirmation (-): 50
- Qualitative/ Positive Agreement (%): 100%
- Qualitative/ Negative Agreement (%): 100%
Method Comparison - Semi-quantitative assay performance (200ng/mL cutoff) verified by LC/MS:
- Test Device (+), LC/MS Confirmation (+): 100
- Test Device (+), LC/MS Confirmation (-): 0
- Test Device (-), LC/MS Confirmation (+): 0
- Test Device (-), LC/MS Confirmation (-): 50
- Semi-Quantitative/ Positive Agreement (%): 100%
- Semi-Quantitative / Negative Agreement (%): 100%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2015
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DR. POMONA CA 91767
Re: K141803
Trade/Device Name: Immunalysis Tramadol Urine Enzyme Immunoassay, Immunalysis Tramadol Urine Controls, Immunalysis Tramadol Urine Calibrators Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DLJ, LAS Dated: December 30, 2014 Received: January 2, 2015
Dear Mr. Joseph Ginete:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -A
For : Courtney H. Lias, Ph.D.
Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141803
Device Name
Immunalysis Tramadol Urine Enzyme Immunalysis Tramadol Urine Controls and Calibrators
Indications for Use (Describe)
Immunalysis Tramadol Urine Enzyme Immunoassay:
The Immunalysis Tramadol Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/ mL. The assay is intended for use in laboratories for the qualitative analysis of Tramadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against Tramadol. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The test is not intended to differentiate between drugs of abuse and prescription use of Tramadol. There are no uniformly recognized drug levels for Tramadol in urine.
The Immunalysis Tramadol Urine Enzyne Immunoassay Kit 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 / Mass Spectroscopy (LC/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.
Immunalysis Tramadol Urine Controls:
The Immunalysis Tramadol Urine Controls are used as control materials in the Immunalysis Tramadol Urine Enzyme Immunoassay.
Immunalysis Tramadol Urine Calibrators:
The Immunalysis Tramadol Urine Calibrators are used as calibrators in the Immunalysis Tramadol Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Tramadol in urine on automated clinical chemistry analyzers.
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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A. Contact Information
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
-
- Manufacturer: Immunalysis Corporation 2. Contact Name: Joseph Ginete 3. Contact Title: Regulatory Affairs Specialist 4. Address: 829 Towne Center Drive Pomona, CA 91767 (909) 482-0840 5. Phone: (909) 482-0850 6. Fax: 7. Email: jginete@immunalysis.com 8. Summary prepared on: February 02, 2015 B. Device Information 1. Trade Name: Immunalysis Tramadol Urine Enzyme Immunoassay Immunalysis Tramadol Urine Controls Immunalysis Tramadol Urine Calibrators 2. Common Name: Immunalysis Tramadol Urine Enzyme Immunoassay Immunalysis Tramadol Urine Controls Immunalysis Tramadol Urine Calibrators C. Requlatory Information 1. Device Classification: Class II Class I, reserved 2. Requlation Number: CFR 862.3650 Opiate Test System CFR 862.3200 Clinical Toxicology Calibrator CFR 862.3280 Clinical Toxicology Control Materials 3. Panel: Toxicology(91) 4. Product Code: DJG DLJ LAS D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3)) LZI Opiate 2000 Enzyme Immunoassay 1. Predicate Device: LZI Opiate 2000 Enzyme Controls
- LZI Opiate 2000 Enzyme Calibrators 2. Predicate Company: Lin-Zhi International Inc. 3. Predicate K Number: K120761
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E. Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes goat antibodies to Tramadol, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjuqate reagent includes tramadol derivative labeled with qlucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The tramadol calibrator and controls consists of a single calibrator at 200ng/mL, a control set containing a LOW control at 150ng/mL and a HIGH control at 250ng/mL and a calibrator set containing a negative calibrator, a Level 1 calibrator at 100ng/mL, a Level 2 calibrator at 200ng/mL, a Level 3 calibrator at 500ng/mL and a Level 4 calibrator at 1000nq/mL.
- F. Intended Use
Immunalysis Tramadol Urine Enzyme Immunoassay:
The Immunalysis Tramadol Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a cutoff of 200ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Tramadol in human urine with automated clinical chemistry analyzers. This assay is calibrated against Tramadol. This in-vitro diagnostic device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The test is not intended to differentiate between drugs of abuse and prescription use of Tramadol. There are no uniformly recognized drug levels for Tramadol in urine.
The Immunalysis Tramadol Urine Enzyme Immunoassay Kit 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 Liguid Chromatography / Mass Spectroscopy (LC/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.
Immunalysis Tramadol Urine Controls:
The Immunalysis Tramadol Urine Controls are used as control materials in the Immunalysis Tramadol Urine Enzyme Immunoassay.
Immunalysis Tramadol Urine Calibrators:
The Immunalysis Tramadol Urine Calibrators are used as calibrators in the Immunalysis Tramadol Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Tramadol in urine on automated clinical chemistry analyzers.
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| Item | Predicate Device (K120761) | Test Device |
|---|---|---|
| Intended Use | For the qualitative and semi-quantitative determination of the presence of opiates in human urine at a cutoff of 2000ng/ml | For the qualitative and semi-quantitative determination of the presence of tramadol in human urine at a cutoff of 200ng/ml |
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Opiates | Tramadol |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 2000ng/mL of Opiates | 200ng/mL of Tramadol |
| Test System | Enzyme Immunoassay | Homogenous Enzyme Immunoassay |
| Materials | R1 antibody reagent and R2 enzyme reagent | Antibody/ Substrate Reagents and Enzyme Labeled Conjugate |
| Mass Spectroscopy Confirmation | Required for preliminary positive analytical results | Required for preliminary positive analytical results |
| Antibody | Mouse monoclonal anti-morphine derivative | Goat Polyclonal Antibody to Tramadol |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | One (1) Level (2000ng/mL) | One (1) Level (200ng/mL) |
| Control Set Levels | Two (2) Levels (1500ng/mL and 2500ng/mL) | Two (2) Levels (150ng/mL and 250ng/mL) |
| Calibrator Set Levels | Five (5) Levels (0, 1000, 2000, 4000 and 6000 ng/mL) | Five (5) Levels (0, 100, 200, 500 and 1000 ng/mL) |
- G. Comparison of the new device with the predicate device
H. Test Principle
-
- Test Principle and Procedure:
This assay uses a Tramadol specific antibody. The assay is based on the competition of Tramadol labeled enzyme glucose-6-phosphate dehydrogenase (G6PDH) and the free drug in the urine sample for the fixed amount of antibody binding sites. In the absence of the free drug 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 sample and enzyme activity. The enzyme G6PDH activity is determined at 340 nm spectrophotometrically by the conversion of NAD to NADH.
- Test Principle and Procedure:
-
l. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Tramadol Urine Enzyme Immunoassay to the predicate
-
- Precision/ Cutoff Characterization Study was performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75% and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. In addition, it also verified the product performance relative to the ability of the device to produce the same value during repeated measurements. The instrument used for this test was a Beckman Coulter AU 400e.
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a.The following is a summary table of the Qualitative Analysis for the 200nq/mL cutoff test data results.
| Qualitative Analysis (for 200ng/mL cutoff) | |||
|---|---|---|---|
| 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 | 44 Negative/36 Positive |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
b.The following is a summary table of the Semi-Quantitative Analysis for the 200ng/mL cutoff test data results.
| Semi-Quantitative Analysis (for 200ng/mL cutoff) | |||
|---|---|---|---|
| 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 | 47 Negative/ 33 Positive |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
Specificity and Cross-Reactivity - Structurally similar compounds were spiked 2. into drug free urine at levels that will vield 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. The instrument used for this test was a Beckman Coulter AU 400e.
a. The qualitative result summary table is outlined below:
| Structurally Related Compounds – Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Tramadol | 200 | N/A | 100.00 |
| n-Desmethyl Tramadol | 450 | POS | 44.4 |
| o-Desmethyl Tramadol | 25,000 | POS | 0.8 |
| Venlafaxine | 100,000 | NEG | N.D. |
| o-Desmethyl Venlafaxine | 100,000 | NEG | N.D. |
N.D. = Not Detected ( 300 ng/mL | Agreement (%) |
| Qualitative/ Positive | 0 | 0 | 10 | 90 | 100% |
| Qualitative/ Negative | 45 | 5 | 0 | 0 | 100% |
c. The following is a comparison table of semi-quantitative assay performance for the 200ng/mL cutoff
| LC/MS Confirmation | ||
|---|---|---|
| Test Device | (+) | (-) |
| (+) | 100 | 0 |
| (-) | 0 | 50 |
- d. The following is a summary table of semi-quantitative assay nerformance for the 200ng/ml_cutoff
| Assay Performance verified by LC/MS – 200ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Tramadol Concentration | Agreement (%) | |||
| 300 ng/mL | |||||
| Semi-Quantitative/ Positive | 0 | 0 | 10 | 90 | 100% |
| Semi-Quantitative / Negative | 45 | 5 | 0 | 0 | 100% |
- Stability -
a. A closed accelerated stability study was performed on reagents.
calibrators and controls at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year for
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reagents. This stability study supported an initial expiration date of 12 months for calibrators and controls. The instrument used for this test was a Beckman Coulter AU 400e.
-
- The following is a summary of the qualitative stability data. The 0 and 150ng/mL levels were negative in comparison to the 200ng/mL cutoff for Day 0. 2. 8. 16. 24. 32 and 40. The 250ng/mL level was positive in comparison to the 200ng/mL cutoff for Day 0, 2, 8, 16, 24, 32 and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
-
- The following is a summary of the semi-quantitative stabililty data for the 200ng/mL cutoff. The 150ng/mL level was negative in comparison to the 200ng/mL cutoff for Day 0, 2, 8, 16, 24, 32 and 40. The 250ng/mL level was positive in comparison to the 200ng/mL cutoff for Day 0, 2, 8, 16, 24, 32 and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- b. An open/ on-board stability study was performed on reagents to establish expiration dating when reagents are opened and stored on board the instrument at 2℃ to 8℃. The stability study supported an initial open vial expiration date of 28 days. The instrument used for this test was a Beckman Coulter AU 400e.
-
- The following is a summary of the qualitative open/ on-board stability data for the 200ng/mL cutoff. All replicates for the 150ng/mL level were negative in comparison to the 200ng/mL cutoff for Day 0, 7, 14, 21 and 28. All replicates of the 250ng/mL level were positive in comparison to the 200ng/mL cutoff for Day 0, 7, 14, 21 and 28.
-
- The following is a summary of the semi-quantitative open/ onboard stability data for the 200ng/mL cutoff. The mean of the replicates for the 150ng/mL level were negative in comparison to the 200ng/mL cutoff for Day 0, 7, 14, 21 and 28. The mean of the replicates of the 250ng/mL level were positive in comparison to the 200ng/mL cutoff for Day 0, 7, 14, 21 and 28.
-
- c. A Specimen and Storage Handling study was performed on a specimen below the cutoff near the bracketing control and a specimen above the cutoff near the bracketing control to establish specimen storage and handling stability at 2 – 8°C. The stability study supported a 1 month specimen storage and handling recommendation at 2 - 8°C.
-
- The following is a summary of the Mass Spectrometry data. The specimen below the cutoff was negative in comparison to the 200ng/mL cutoff for Day 0, Week 1, 2, 3 and 4. The specimen above the cutoff was positive in comparison to the 200ng/mL cutoff for Day 0, Week 1, 2, 3 and 4.
-
-
- Calibrator and Control Traceability all components of the calibrator and controls have been traced to a commercially available standard solution from Cerilliant Chemicals.
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- Calibrator and Control Stability An open accelerated stability study was performed at 37°C to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 6 months. The instrument used for this test was a Beckman Coulter AU 400e. All calibrator levels (100, 200, 500 and 1000ng/mL) and control levels (150 and 250ng/mL) were within specifications for Day 0, 3, 7, 10 and 13. This accelerated stability study was
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performed to establish initial expiration dating. Real time stability studies are onqoing.
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- Calibrator and Control Value Assignment calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are out of the acceptable range, then the calibrator or control is adjusted and retested. Values are assigned to the calibrator and controls once the Mass spectrometry results are within the acceptable ranges.
- J. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Tramadol Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.