(59 days)
Not Found
No
The description focuses on a homogeneous enzyme immunoassay and its components, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies are standard analytical chemistry validations.
No
This device is an in-vitro diagnostic assay used for the qualitative and semiquantitative analysis of EDDP in human urine, which provides preliminary analytical test results and is not used for treating or diagnosing a disease.
Yes
The device is an in-vitro diagnostic device designed for the qualitative and semiquantitative analysis of EDDP in human urine, which is used to assist in determining an appropriate dilution for confirmation by other methods. It provides a preliminary analytical test result used for clinical consideration and professional judgment.
No
The device description clearly outlines physical reagents (antibody/substrate reagent, enzyme conjugate reagent, calibrators, and controls) which are integral components of the assay. This indicates it is a hardware-based in-vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "This in-vitro device is for prescription use only." This directly identifies it as an in-vitro device.
- Nature of the Test: The device performs a "homogeneous enzyme immunoassay" for the analysis of EDDP in human urine. This is a laboratory test performed on a biological sample outside of the body, which is the definition of an in-vitro diagnostic test.
- Device Description: The description details reagents (antibody/substrate and enzyme conjugate) used to perform the assay on urine samples. This further supports its use as an in-vitro test.
- Performance Studies: The performance studies described (Precision, Specificity, Interference, Linearity, Method Comparison, Stability, Calibrator and Control Analytical Performance) are typical studies conducted to validate the performance of an in-vitro diagnostic device.
- Intended User: The intended user is "laboratories," which is consistent with the use of an IVD.
N/A
Intended Use / Indications for Use
Immunalysis EDDP Specific Urine Enzyme Immunoassay
The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. This in-vitro 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 Immunalysis EDDP Specific Urine Enzyme Immunoassay Kit 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.
Immunalysis EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.
Immunalysis EDDP Urine Control Sets
The Immunalysis EDDP Urine Control Sets are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.
Product codes (comma separated list FDA assigned to the subject device)
DJR, DLJ, LAS
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant fab antibodies to EDDP. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
2. All of the Immunalysis EDDP Calibrators and Controls are liquid and ready to use. These calibrators and controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2, and LOW Control 3 and HIGH Control 3 are prepared by spiking known concentrations of EDDP into the negative calibrator matrix. These five calibrators and six controls are sold as individual bottles. The concentration of EDDP in their corresponding calibrators and controls are summarized as follows:
| Analyte | EDDP Calibrators | EDDP Controls | EDDP Controls | EDDP Controls | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 4 | LOW Control 1 | HIGH Control 1 | LOW Control 2 | HIGH Control 2 | LOW Control 3 | HIGH Control 3 | |
| EDDP (ng/mL) | 100 | 300 | 500 | 1000 | 75 | 125 | 225 | 375 | 750 | 1250 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratories for the qualitative and semi-quantitative analysis of EDDP in human urine 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision/ Cutoff Characterization/ Reproducibility: Study performed for 20 days, 2 runs per day in duplicate (N=80) on concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff (100 ng/mL, 300 ng/mL, 1000 ng/mL). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result and that the product can produce the same value during repeated measurements. Instruments used: Beckman Coulter AU 400e. Key results are summarized in tables 2, 3, 4, 5, and 6, showing the number of positive/negative results at different concentrations relative to the cutoff.
- Specificity and Cross-Reactivity: Structurally similar compounds were spiked into drug-free urine at levels that would yield a result equivalent to the cutoffs. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. Instrument used: Beckman Coulter AU 400e. Key results detailed in Tables 7, 8, 9, 10, and 11, showing cross-reactivity percentages for various compounds at different cutoff levels.
- Interference: Structurally non-similar compounds, endogenous compounds, and the effects of pH and specific gravity were evaluated by spiking potential interferents into drug-free urine containing the target analyte at ±25% of the cutoff. The study verified that assay performance is unaffected by externally ingested compounds or internally existing physiological conditions. Instrument used: Beckman Coulter AU 400e. Key results are presented in Tables 12, 13, 14 (structurally non-similar compounds), Tables 15, 16, 17 (endogenous compounds), Tables 18, 19, 20, 21, 22, 23 (Boric Acid), and Tables 24, 25, 26 (effect of pH), and Tables 27, 28, 29 (effect of specific gravity). Boric Acid interferes with the assay, and this limitation was added to labeling. Specific falsely low/high results for certain compounds were noted for the 100ng/mL cutoff.
- Linearity/ Recovery: A drug-free urine pool was spiked with a high concentration of the target analyte. Additional pools were made by serially diluting the high-value specimen. This study verified assay linearity in the semi-quantitative mode. Instrument used: Beckman Coulter AU 400e. Key results in Table 30 show mean concentrations and recovery percentages for expected concentrations from 0 to 1100 ng/mL. The study successfully verified that product performance can meet design specifications for semi-quantitative mode.
- Method Comparison: Unaltered, anonymous, and discarded clinical urine samples were analyzed with the test device and compared against Mass Spectrometry. Instrument used: Beckman Coulter AU 400e and Agilent 6430 Liquid Chromatography Tandem Mass Spectrometry. Key results are summarized in Tables 31, 32, 34, 35, 36, 37 (qualitative assay performance per cutoff, showing agreement percentages) and Tables 38, 39, 41, 42 (semi-quantitative assay performance per cutoff, showing agreement percentages). A discordant result for the 100ng/mL cutoff is presented in Table 33 and Table 40 for qualitative and semi-quantitative analyses, respectively.
- Stability:
- Closed accelerated stability: Performed on reagents at 25°C. Supported an initial expiration date of 1 year at 2-8°C for reagents. Real stability studies are ongoing. Instrument: Beckman Coulter AU 400e.
- Open vial stability: Performed on reagents at 25°C. Supported an initial expiration date of 1 year at 2-8°C for reagents. Real stability studies are ongoing. Instrument: Beckman Coulter AU 400e.
- Open/on-board stability: Performed on reagents stored on board the instrument at 2℃ to 8℃. Supported an initial open vial expiration date of 28 days at 2-8°C. Instrument: Beckman Coulter AU 400e.
- Calibrator and Control Analytical Performance:
- Traceability: All components traced to a commercially available standard solution.
- Open Vial Stability: Accelerated study at 37℃. Supported initial open vial expiration of 1 year at 2-8°C for calibrators and controls. All levels were within specifications for Day 0, 3, 7, 10, and 13. Real time studies ongoing. Instrument: Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer.
- Closed Vial Upright Stability: Accelerated study at 37℃. Supported initial 1 year expiration at 2-8°C for calibrators and controls. All levels were within specifications for Day 0, 3, 7, 10, and 13. Real time studies ongoing. Instrument: Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer.
- Closed Vial Inverted Stability: Accelerated study at 37°C. Supported initial 1 year expiration at 2-8°C for calibrators and controls. All levels were within specifications for Day 0, 3, 7, 10, and 13. Real time studies ongoing. Instrument: Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer.
- Value Assignment: Calibrators and controls manufactured and tested by mass spectrometry. Adjusted and re-tested if analytes not in acceptable range. Values assigned once mass spectrometry results are within acceptable ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Qualitative Assay Performance verified by LC/MS – 100ng/mL Cutoff (Table 32):
- Qualitative/Positive Agreement: 98%
- Qualitative/Negative Agreement: 100%
Qualitative Assay Performance verified by LC/MS – 300ng/mL Cutoff (Table 35):
- Qualitative/Positive Agreement: 100%
- Qualitative/Negative Agreement: 100%
Qualitative Assay Performance verified by LC/MS – 1000ng/mL Cutoff (Table 37):
- Qualitative/Positive Agreement: 100%
- Qualitative/Negative Agreement: 100%
Semi-Quantitative Assay Performance verified by LC/MS – 100ng/mL Cutoff (Table 39):
- Semi-Quantitative/Positive Agreement: 98%
- Semi-Quantitative/Negative Agreement: 100%
Semi-Quantitative Assay Performance verified by LC/MS – 300ng/mL Cutoff (Table 42):
- 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
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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
July 24, 2015
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767
Re: K151395
Trade/Device Name: Immunalysis EDDP Specific Urine Enzyme Immunoassay. Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: II Product Code: DJR, DLJ, LAS Dated: May 22, 2015 Received: May 26, 2015
Dear 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/Resourcesfor You/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,
Courtney H. Lias -S
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) K151395
Device Name
Immunalysis EDDP Specific Urine Enzyme Immunoassay Immunalysis EDDP Urine Calibrators Immunalysis EDDP Urine Control Sets
Indications for Use (Describe)
Immunalysis EDDP Specific Urine Enzyme Immunoassay
The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with cutoffs of 100 ng/mL, 300n g/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. This assay is calibrated against EDDP. This in-vitro 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 Immunalysis EDDP Specific Urine Enzyme Immunoassay Kit 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.
Immunalysis EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.
Immunalysis EDDP Urine Control Sets
The Immunalysis EDDP Urine Control Sets are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.
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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).
- A. Contact Information
| 1. | Manufacturer: | Immunalysis Corporation |
|---|---|---|
| 2. | Contact Name: | Joseph Ginete |
| 3. | Contact Title: | Regulatory Affairs Specialist II |
| 4. | Address: | 829 Towne Center Drive Pomona, CA 91767 |
| 5. | Phone: | (909) 482-0840 |
| 6. | Fax: | (909) 482-0850 |
| 7. | Email: | jginete@immunalysis.com |
| 8. | Summary prepared on: | July 8, 2015 |
| B. Device Information | ||
| 1. Trade Name: | Immunalysis EDDP Specific Urine Enzyme Immunoassay | |
| Immunalysis EDDP Calibrators and Control Sets | ||
| 2. | Common Name: | Immunalysis EDDP Specific Urine Enzyme Immunoassay |
| Immunalysis EDDP Calibrators and Control Sets | ||
| C. Regulatory Information | ||
| 1. Device Classification: | II | |
| I, reserved | ||
| 2. Regulation Number: | 21 CFR862.3250 Enzyme Immunoassay, Methadone | |
| 21 CFR 862.3200 Calibrator, Drug Specific | ||
| 21 CFR 862.3280 Drug Specific Control Materials | ||
| 3. Panel: | Toxicology(91) | |
| 4. | Product Code: | DJR |
| DLJ | ||
| LAS |
- D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
-
- Predicate Device: DRI® Methadone Metabolite Enzyme Immunoassay
-
- Predicate Company: Microgenics
-
- Predicate K Number: K023617
-
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- E. Device Description
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. 1. The antibody/ substrate reagent includes recombinant fab antibodies to EDDP. glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes EDDP derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative.
-
- All of the Immunalysis EDDP Calibrators and Controls are liquid and ready to use. These calibrators and controls do not have any especially unique technical characteristics. Each contains a known concentration of a specific drug analyte as a mixture.
The negative calibrator is a processed, drug-free synthetic urine matrix with sodium azide as a preservative. The Level 1, 2, 3 and 4 calibrators, as well as the LOW Control 1, HIGH Control 1, LOW Control 2 and HIGH Control 2, and LOW Control 3 and HIGH Control 3 are prepared by spiking known concentrations of EDDP into the negative calibrator matrix. These five calibrators and six controls are sold as individual bottles. The concentration of EDDP in their corresponding calibrators and controls are summarized as follows:
| Analyte | EDDP Calibrators | EDDP Controls | EDDP Controls | EDDP Controls | ||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Level 4 | LOW Control 1 | HIGH Control 1 | LOW Control 2 | HIGH Control 2 | LOW Control 3 | HIGH Control 3 | |
| EDDP (ng/mL) | 100 | 300 | 500 | 1000 | 75 | 125 | 225 | 375 | 750 | 1250 |
esponding Calibrators and Controls are Summarized as follows:
Table 1: Immunoassay EDDP Urine Calibrators and Controls
F. Intended Use
- The Immunalysis EDDP Specific Urine Enzyme Immunoassay is a homogeneous 1. enzyme immunoassay with cutoffs of 100ng/mL, 300ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of EDDP in human urine with automated clinical chemistry analyzers. The 100ng/mL and 300ng/mL cutoff is for qualitative and semi-quantitative analysis. The 1000ng/mL cutoff is for qualitative analysis only. This assay is calibrated against EDDP. 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 Immunalysis EDDP Specific 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
5
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.
-
- Immunalysis EDDP Urine Controls
The Immunalysis EDDP Urine Controls are used as control materials in Immunalysis EDDP Specific Urine Enzyme Immunoassay.
- Immunalysis EDDP Urine Controls
-
- Immunalysis EDDP Urine Calibrators
The Immunalysis EDDP Urine Calibrators are used as calibrators in the Immunalysis EDDP Specific Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of EDDP in urine on automated clinical chemistry analyzers.
- Immunalysis EDDP Urine Calibrators
| Item | EDDP Assay K023617 | Immunalysis EDDP Specific Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi- | |
| quantitative determination of the | ||
| presence of EDDP in human urine at a | ||
| cutoff of 300ng/mL and 1000ng/mL | For the qualitative and semi-quantitative | |
| determination of the presence of EDDP in | ||
| human urine at a cutoff of 100ng/mL, | ||
| 300ng/mL and 1000ng/mL | ||
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured | ||
| Analytes | EDDP | EDDP |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 300ng/mL and 1000ng/mL of EDDP | 100ng/mL, 300ng/mL and 1000ng/mL of |
| EDDP | ||
| Test System | Homogeneous Enzyme Immunoassay | Homogenous Enzyme Immunoassay |
| Materials | Antibody/Substrate Reagents and | |
| Enzyme Labeled Conjugate | Antibody/Substrate Reagents and Enzyme | |
| Labeled Conjugate | ||
| Mass | ||
| Spectroscopy | ||
| Confirmation | Required for preliminary positive | |
| analytical results | Required for preliminary positive analytical | |
| results | ||
| Antibodv | Mouse Monoclonal antibodies to | |
| EDDP | Recombinant antibody to EDDP | |
| Storage | 2 - 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Four (4) Levels | Four (4) Levels |
| Control Levels | Four (4) Levels | Six (6) Levels |
G. Comparison of the new device with the predicate device
- H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis EDDP Specific Urine Enzyme Immunoassay to the predicate
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IMMUNALYSIS
-
- Precision/ Cutoff Characterization/ Reproducibility 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 that product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was Beckman Coulter AU 400e.
| a. The following is a summary table of the Qualitative Analysis for the |
|---|
| 100ng/mL cutoff test data results. |
| Table 2 - Qualitative Analysis (for 100ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 25 | -75% | 80 | 80 Negative |
| 50 | -50% | 80 | 80 Negative |
| 75 | -25% | 80 | 80 Negative |
| 100 | Cutoff | 80 | 43 Negative/37 Positive |
| 125 | +25% | 80 | 80 Positive |
| 150 | +50% | 80 | 80 Positive |
| 175 | +75% | 80 | 80 Positive |
| 200 | +100% | 80 | 80 Positive |
b. The following is a summary table of the Qualitative Analysis for the 300ng/mL cutoff test data results.
| Table 3 - Qualitative Analysis (for 300 ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 75 | -75% | 80 | 80 Negative |
| 150 | -50% | 80 | 80 Negative |
| 225 | -25% | 80 | 80 Negative |
| 300 | Cutoff | 80 | 40 Negative / 40 Positive |
| 375 | +25% | 80 | 80 Positive |
| 450 | +50% | 80 | 80 Positive |
| 525 | +75% | 80 | 80 Positive |
| 600 | +100% | 80 | 80 Positive |
c. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results.
| Table 4 - Qualitative Analysis (for 1000 ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 250 | -75% | 80 | 80 Negative |
| 500 | -50% | 80 | 80 Negative |
| 750 | -25% | 80 | 80 Negative |
| 1000 | Cutoff | 80 | 46 Negative / 34 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |
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| Table 5 - Semi-Quantitative Analysis (for 100ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 25 | -75% | 80 | 80 Negative |
| 50 | -50% | 80 | 80 Negative |
| 75 | -25% | 80 | 80 Negative |
| 100 | Cutoff | 80 | 10 Negative / 70 Positive |
| 125 | +25% | 80 | 80 Positive |
| 150 | +50% | 80 | 80 Positive |
| 175 | +75% | 80 | 80 Positive |
| 200 | +100% | 80 | 80 Positive |
d. The following is a summary table of the Semi-Quantitative Analysis for the 100ng/mL cutoff test data results.
e. The following is a summary table of the Semi-Quantitative Analysis for the 300ng/mL cutoff test data results.
| Table 6 - Semi-Quantitative Analysis (for 300ng/mL cutoff) | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Result |
| 0 | -100% | 80 | 80 Negative |
| 75 | -75% | 80 | 80 Negative |
| 150 | -50% | 80 | 80 Negative |
| 225 | -25% | 80 | 80 Negative |
| 300 | Cutoff | 80 | 13 Negative / 67 Positive |
| 375 | +25% | 80 | 80 Positive |
| 450 | +50% | 80 | 80 Positive |
| 525 | +75% | 80 | 80 Positive |
| 600 | +100% | 80 | 80 Positive |
-
- 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 cutoffs. 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 for the 100ng/mL cutoff is outlined below:
| Table 7 - Structurally Related Compounds (for 100 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| EDDP | 100 | Positive | 100 |
| Methadone | 700,000 | Positive | 0.01 |
| EMDP | 1,000,000 | Negative | 150 ng/mL |
| Qualitative/ | |||
| Positive | 0 | 1 | 4 |
| Qualitative/ | |||
| Negative | 36 | 3 | 0 |
c. The following is a summary table of qualitative discordant results for the 100ng/mL cutoff:
| Sample ID | In-House ID | Qualitative Results 100ng Cutoff
Test Device | LC/MS Confirmation
EDDP |
|-----------|-------------|-------------------------------------------------|----------------------------|
| JM042877 | 15980 | POS | 97.0 |
d. The following is a comparison table of qualitative assay performance for the 300ng/mL cutoff:
- Table 34 Method Comparison (for 300ng/mL cutoff) Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 0 |
| (-) | 0 | 40 |
- e. The following is a summary table of the qualitative assay performance for the 300ng/mL cutoff:
| Table 35 - Assay Performance verified by LC/MS – 300ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | EDDP Concentration | Agreement (%) | |||
| 450 ng/mL | |||||
| Qualitative/ | |||||
| Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/ | |||||
| Negative | 36 | 4 | 0 | 0 | 100 |
f. The following is a comparison table of qualitative assay performance for the 1000ng/mL cutoff:
Table 36 - Method Comparison (for 1000ng/mL cutoff) - Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 0 |
| (-) | 0 | 40 |
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| for the 1000ng/mL cutoff: | |||||
|---|---|---|---|---|---|
| Table 37 - Assay Performance verified by LC/MS – 1000ng/mL Cutoff | |||||
| Type | EDDP Concentration | Agreement | |||
| (%) | |||||
| 1500 ng/mL | |||||
| Qualitative/ | |||||
| Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/ | |||||
| Negative | 36 | 4 | 0 | 0 | 100 |
- g. The following is a summary table of the qualitative assay performance
- h. The following is a comparison table of semi-quantitative assay performance for the 100ng/mL cutoff:
Table 38 - Method Comparison (for 100ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 1 |
| (-) | 0 | 39 |
i. The following is a summary table of semi-quantitative assay performance for the 100ng/mL cutoff:
| Type | EDDP Concentration | Agreement (%) | |||
|---|---|---|---|---|---|
| 150 ng/mL | |||||
| Semi-Quantitative/ | |||||
| Positive | 0 | 1 | 4 | 36 | 98 |
| Semi-Quantitative / | |||||
| Negative | 36 | 3 | 0 | 0 | 100 |
- j. The following is a summary table of semi-quantitative assay performance for the 100ng/mL:
| Table 40 - Discordant Result Summary – 100ng/mL Cutoff - Semi-
| Quantitative | ||||
|---|---|---|---|---|
| Sample ID | In-House ID | Semi-Quantitative Results | ||
| 100ng Cutoff | LC/MS Confirmation | |||
| Value | Result | EDDP | ||
| JM042877 | 15980 | 149.5 | POS | 97.0 |
k.The following is a comparison table of semi-quantitative assay performance for the 300ng/mL cutoff:
Table 41 - Method Comparison (for 300ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 0 |
| (-) | 0 | 40 |
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| Type | EDDP Concentration | Agreement (%) | |||
|---|---|---|---|---|---|
| 450 ng/mL | |||||
| Semi-Quantitative/ | |||||
| Positive | 0 | 0 | 4 | 36 | 100 |
| Semi-Quantitative / | |||||
| Negative | 36 | 4 | 0 | 0 | 100 |
-
- The following is a summary table of semi-quantitative assay performance
6. Stability -
- a. A closed accelerated stability study was performed on reagents at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year at 2 - 8°C for reagents. The instrument used for this test was Beckman Coulter AU 400e. Real stability studies are ongoing.
- b.An open vial stability study was performed on reagents at 25°C to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year at 2 - 8°C for reagents. The instrument used for this test was Beckman Coulter AU 400e. Real stability studies are ongoing.
- c. 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 at 2 – 8°C. The instrument used for this test was Beckman Coulter AU 400e.
-
- Calibrator and Control Analytical Performance Immunalysis EDDP Urine Calibrators and Controls
- a. EDDP Calibrators and Controls Traceability all components of the calibrators and controls have been traced to a commercially available standard solution.
- b. EDDP Calibrators and Controls Open Vial Stability An open vial accelerated stability study was performed at 37℃ to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 1 year at 2 - 8°C for calibrators and controls. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control 1, 2, and 3 and High Control 1, 2, and 3) for EDDP were within specifications for Day 0. 3. 7. 10. and 13. This stability study was performed to establish initial expiration dating.
- c. EDDP Calibrators and Controls Closed Vial Upright Stability A closed vial upright accelerated stability study was performed at 37℃ to establish the initial vial expiration dating. The stability study supported an initial expiration date of 1 year at 2 - 8°C for calibrators and controls. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control 1, 2,
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and 3 and High Control 1, 2, and 3) for EDDP were within specifications for Day 0, 3, 7, 10, and 13. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- d. EDDP Calibrators and Controls Closed Vial Inverted Stability A closed vial inverted accelerated stability study was performed at 37°C to establish the initial vial expiration dating. The stability study supported an initial expiration date of 1 year at 2 - 8°C for calibrators and controls. The instrument used for this test was an Agilent 1200 Series Liquid Chromatograph coupled to Agilent 6410 Tandem Mass Spectrometer. All calibrator levels (1, 2, 3, and 4) and all control levels (Low Control 1, 2, and 3 and High Control 1, 2, and 3) for EDDP were within specifications for Day 0. 3. 7. 10. and 13. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
- e. EDDP Calibrators and Controls Value Assignment Calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are not of the acceptable range, then the calibrator and controls is adjusted and re-tested. Values are assigned to the calibrators and controls once the mass spectrometry results are within the acceptable ranges.
- I. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis EDDP Specific Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.