(411 days)
Not Found
No
The device description and performance studies focus on a biochemical enzyme immunoassay and standard analytical methods, with no mention of AI or ML.
No
The device is an in vitro diagnostic device used for the qualitative analysis of Fentanyl in human urine. It does not provide any treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is for prescription use only." Additionally, the assay is intended for "qualitative analysis of Fentanyl in human urine," which is a diagnostic purpose.
No
The device is an in vitro diagnostic assay that utilizes chemical reagents and requires automated clinical chemistry analyzers for operation. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section: "This in vitro diagnostic device is for prescription use only."
Furthermore, the entire description aligns with the definition of an in vitro diagnostic device, as it is intended for the qualitative analysis of a substance (Fentanyl) in a human specimen (urine) using laboratory methods (enzyme immunoassay) to provide information for medical purposes (preliminary analytical test result for drug of abuse testing).
N/A
Intended Use / Indications for Use
The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only.
The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay 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 / Mass Spectrometry (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 Fentanyl Urine Calibrators:
The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl in urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DJG, DLJ
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes EA protein and rabbit antibodies to Fentanyl in PIPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes ED peptide labeled with Fentanyl and CPRG substrate in malic acid buffer with sodium azide as a preservative. Calibrators and controls are included as part of the test system and provided separately. The Fentanyl calibrators consist of a Level 1 calibrator at 1 ng/mL, a Level 2 calibrator at 2 ng/mL, and a Level 3 calibrator at 4 ng/mL. The control set contains a LOW control at 0.5 ng/mL and a HIGH control at 1.5 ng/mL.
Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates at 570nm can be used to perform the assay.
The SEFRIA™ technology is based on artificial fragments of the E. coli enzyme beta-galactosidase. A mutant enzyme, termed Enzyme Acceptor (EA), is created by deletion of 28 amino acids in the amino-terminal region of the sequence. EA is inactive, but can combine with peptides, termed Enzyme Donors (ED's), containing the deleted sequence, to form active B-galactosidase. This process is termed complementation, and the active enzyme formed as a result can be measured by hydrolysis of a chromogenic substrate such as chlorophenolred beta-D-galactopyranoside (CPRG). The ED peptides can be modified by attachment of a derivative of fentanyl, which does not interfere with the formation of active beta-galactosidase. However antibodies to fentanyl bind to the ED-fentanyl conjugate, and block complementation. The assay is based on the competition of fentanyl in a urine sample with the ED-fentanyl conjugate for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the ED-fentanyl conjugate, resulting in inhibition of enzyme formation. As the fentanyl concentration in the sample increases, ED-fentanyl becomes available for complementation, creating a dose response relationship between fentanyl concentration in the urine and enzyme formation. The B-galactosidase activity is determined spectrophotometrically at 570 nm by the conversion of CPRG (orange) to chlorophenol red (red) and galactose.
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
80 deidentified, unaltered leftover clinical urine samples obtained from clinical testing laboratories were analyzed for fentanyl at an assay cutoff of 1.0 ng/mL with the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay compared to results by mass spectrometry (LC-MS/MS). The instruments used were a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometer.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision/ Cutoff Characterization/ Reproducibility Study: performed for 10 days, 2 runs per day in replicates of 4 on drug free urine (N=80) spiked with fentanyl to concentrations of plus/minus 25%, plus/minus 50%, plus/minus 75%, and plus/minus 100% of the cutoff (1.0 ng/mL). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. Sample size N=80 per concentration level. Total 9 concentration levels evaluated.
- 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. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs.
- Interference (Structurally Unrelated Compounds): Structurally unrelated compounds were evaluated by spiking the potential interferent into drug free urine containing fentanyl at plus/minus 50% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds.
- Interference (Endogenous Compounds): Endogenous compounds were evaluated by spiking the potential interferent into drug free urine containing fentanyl at plus/minus 50% of the cutoff. All potential interferents analyzed verified that assay performance is unaffected by internally existing physiological conditions.
- Boric Acid Interference: Boric acid at a concentration of 1% w/v was evaluated by spiking the potential interferent into drug free urine containing fentanyl at plus/minus 50% of the cutoff.
- pH Interference: Device performance was tested using a range of urine pH values (3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0 and 11.0). All test samples were prepared in drug free urine containing fentanyl at plus/minus 50% of the cutoff. No positive or negative interference was observed.
- Specific Gravity Interference: Device performance was tested using a range of physiologically relevant urine specific gravity values (1.000, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030). All test samples were prepared in drug free urine containing fentanyl at plus/minus 50% of the cutoff. No positive or negative interference was observed.
- Linearity/ Recovery: Not applicable, this device is intended for qualitative use only.
- Method Comparison: Sample size N=80. Eighty deidentified, unaltered leftover clinical urine samples obtained from clinical testing laboratories were analyzed for fentanyl at an assay cutoff of 1.0 ng/mL with the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay compared to results by mass spectrometry (LC-MS/MS). Agreement for positive cases was 100% (40/40), and for negative cases it was 98% (39/40). One discordant result was noted where the test device gave a positive result (0.9 ng/mL by LC/MS confirmation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement (for samples with LC/MS value 1.5 ng/mL or 0.50.9 ng/mL classified as negative and 1.01.5 ng/mL as positive):
Positive Agreement: 100% (40/40)
Negative Agreement: 98% (39/40)
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 14, 2017
IMMUNALYSIS CORPORATION MICHELLE BODIEN, ASSOCIATE DIRECTOR, REGULATORY AFFAIRS 829 TOWNE CENTER DRIVE POMONA, CA 91767
Re: K161216
Trade/Device Name: Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay and Immunalysis Fentanyl Urine Calibrators Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DLJ Dated: May 30, 2017 Received: June 1, 2017
Dear Ms. Bodien:
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
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,
Kellie B. Kelm -S
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
2
Indications for Use
510(k) Number (if known) K161216
Device Name
Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators
Indications for Use (Describe)
The Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This assay is calibrated against Fentanyl. This in vitro diagnostic device is for prescription use only.
The Immunalysis SEFRIA Fentanyl Urine Enzyne Immunoassay 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 / Mass Spectrometry (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 Fentanyl Urine Calibrators:
The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
| A. General Information | |||
|---|---|---|---|
| 1. | Applicant Name: | Immunalysis Corporation | |
| 829 Towne Center Drive | |||
| Pomona, CA 91767 | |||
| 2. | Company Contact: | Michelle Bodien | |
| Associate Director, Regulatory Affairs | |||
| Phone: (858) 805-2283 | |||
| Email: michelle.bodien@alere.com | |||
| 3. | Date prepared: | June 13, 2017 | |
| B. Device Identification | |||
| 1. | Trade Name: | Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay | |
| Immunalysis Fentanyl Urine Calibrators | |||
| 2. | Common Name: | Fentanyl Urine Enzyme Immunoassay | |
| Fentanyl Urine Calibrators | |||
| C. Regulatory Information | |||
| 1. | Device Classification: | II | |
| 2. | Regulation Number: | 21 CFR 862.3650 Enzyme Immunoassay,Opiates | |
| 21 CFR 862.3200 Calibrators, Drug Specific | |||
| 3. | Panel: | Toxicology (91) | |
| 4. | Product Code: | DJG | |
| DLJ | |||
| 5. | Predicate Device: | Emit® II Plus Buprenorphine Assay | |
| 6. | Predicate Company: | Siemens Healthcare Diagnostics Inc. | |
| 7. | Predicate K Number: | K150606 |
4
D. Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes EA protein and rabbit antibodies to Fentanyl in PIPES buffer with sodium azide as a preservative. The enzyme conjugate reagent includes ED peptide labeled with Fentanyl and CPRG substrate in malic acid buffer with sodium azide as a preservative. Calibrators and controls are included as part of the test system and provided separately. The Fentanyl calibrators consist of a Level 1 calibrator at 1 ng/mL, a Level 2 calibrator at 2 ng/mL, and a Level 3 calibrator at 4 ng/mL. The control set contains a LOW control at 0.5 ng/mL and a HIGH control at 1.5 ng/mL.
Automated clinical chemistry analyzers capable of maintaining a constant temperature, pipetting samples and reagents, mixing reagents, timing the reaction accurately and measuring enzymatic rates at 570nm can be used to perform the assay.
The SEFRIA™ technology is based on artificial fragments of the E. coli enzyme ß-galactosidase. A mutant enzyme, termed Enzyme Acceptor (EA), is created by deletion of 28 amino acids in the amino-terminal region of the sequence. EA is inactive, but can combine with peptides, termed Enzyme Donors (ED's), containing the deleted sequence, to form active B-galactosidase. This process is termed complementation, and the active enzyme formed as a result can be measured by hydrolysis of a chromogenic substrate such as chlorophenolred ß-D-galactopyranoside (CPRG). The ED peptides can be modified by attachment of a derivative of fentanyl, which does not interfere with the formation of active ß-galactosidase. However antibodies to fentanyl bind to the ED-fentanyl conjugate, and block complementation. The assay is based on the competition of fentanyl in a urine sample with the ED-fentanyl conjugate for the fixed amount of antibody binding sites. In the absence of the free drug in the sample, the antibody binds the ED-fentanyl conjugate, resulting in inhibition of enzyme formation. As the fentanyl concentration in the sample increases, ED-fentanyl becomes available for complementation, creating a dose response relationship between fentanyl concentration in the urine and enzyme formation. The Bgalactosidase activity is determined spectrophotometrically at 570 nm by the conversion of CPRG (orange) to chlorophenol red (red) and galactose.
E. Intended Use
-
- The Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay is an in vitro diagnostic test for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This test is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories and for prescription use only. This assay is calibrated against Fentanyl.
The Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay 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 / Mass Spectrometry (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.
- The Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay is an in vitro diagnostic test for the qualitative analysis of Fentanyl in human urine with automated clinical chemistry analyzers. This test is an enzyme immunoassay with a cutoff of 1.0 ng/mL. The assay is intended for use in laboratories and for prescription use only. This assay is calibrated against Fentanyl.
5
2. Immunalysis Fentanyl Urine Calibrators
The Immunalysis Fentanyl Urine Calibrators are used as calibrators in the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay for the qualitative determination of Fentanyl in urine on automated clinical chemistry analyzers.
| Attribute | Predicate Device K150606
Emit® II Plus Buprenorphine Assay | Candidate Device
Immunalysis Fentanyl Urine EIA |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Similarities | | |
| Test System | Homogeneous enzyme immunoassay | Same |
| Sample Matrix | Urine | Same |
| User Environment | For use in laboratories | Same |
| Mass Spectrometry Confirmation | Required for preliminary positive analytical results | Same |
| Storage | 2 – 8° C | Same |
| Materials | Antibody/substrate reagents and enzyme labeled conjugate | Same |
| Calibrator Form | Liquid | Same |
| Differences | | |
| Intended Use | For the qualitative and semi-quantitative determination of the presence of Buprenorphine in human urine at a cutoff of 5 ng/mL | For the qualitative determination of the presence of Fentanyl in human urine at a cutoff of 1 ng/mL |
| Detection | Absorbance change measured spectrophotometrically at 340 nm | Absorbance change measured spectrophotometrically at 570 nm |
| Measured Analytes | Buprenorphine | Fentanyl |
| Cutoff Levels | 5 ng/mL of Buprenorphine | 1 ng/mL of Fentanyl |
| Antibody | Mouse monoclonal antibody to buprenorphine | Rabbit antibodies to Fentanyl |
| Reagents Form | R1 and R2: Liquid – Ready to use | EA and ED: Liquid – Ready to use |
| Calibrator Levels | One negative and four levels (0, 2.5, 5, 15 and 25 ng/mL) | One negative and three levels (0, 1, 2 and 4 ng/mL |
F. Comparison With Predicate
6
-
G. Performance Characteristics:
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis SEFRIATM Fentanyl Urine Enzyme Immunoassay to the predicate. All studies utilized the Beckman Coulter AU 400e instrument. -
- Precision/ Cutoff Characterization/ Reproducibility Study was performed for 10 days, 2 runs per day in replicates of 4 on drug free urine (N=80) spiked with fentanyl to concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff (1.0 ng/mL). The spiked concentrations were confirmed by mass spectrometry (MS). The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result.
| Table 1 - Precision Results | |||
|---|---|---|---|
| Concentration (ng/mL) | % of cutoff | # of determinations | Total Result |
| 0 | -100% | 80 | 80 Negative |
| 0.25 | -75% | 80 | 80 Negative |
| 0.5 | -50% | 80 | 80 Negative |
| 0.75 | -25% | 80 | 80 Negative |
| 1.0 | Cutoff | 80 | 32 Negative/48 Positive |
| 1.25 | +25% | 80 | 80 Positive |
| 1.5 | +50% | 80 | 80 Positive |
| 1.75 | +75% | 80 | 80 Positive |
| 2.0 | +100% | 80 | 80 Positive |
The following is a summary table precision results for the 1.0 ng/mL cutoff test data results.
-
- 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. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs.
7
| Table 3 - Structurally Related Compounds | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Fentanyl | 1 | Positive | 100.0000 |
| Butyryl Fentanyl | 0.8 | Positive | 125.0000 |
| Acetyl Fentanyl | 1 | Positive | 100.0000 |
| Despropionyl Fentanyl | 40 | Positive | 2.5000 |
| Sufentanil | 175 | Negative | 1.5 |
| ng/mL | Agreement | ||
| (%) | |||
| Positive | 0 | 1 | 9 |
| (40/40) | |||
| Negative | 30 | 9 | 0 |
| (39/40) |
The following is a summary table of qualitative discordant results for the 1.0 ng/mL cutoff:
| Table 13 - Discordant Result Summary | |||
|---|---|---|---|
| Sample ID | In-House ID | 1ng Cutoff | |
| Test Device | LC/MS Confirmation | ||
| Negative 36 | 21378 | Positive | 0.9 ng/mL |
10. Immunalysis Fentanyl Urine Calibrators
- Traceability all components of the calibrators have been traced to a commercially available a. fentanyl solution.
- Value Assignment Calibrators are manufactured and tested by mass spectrometry. The b. negative calibrator is a processed, drug free urine matrix. The negative calibrator is compared to a reference negative standard to ensure that it is free of analyte. The non-zero calibrators are prepared by spiking a known concentration of fentanyl in the negative calibrator matrix. If any of the analytes are not within the acceptable range, then the calibrator is adjusted and retested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
H. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis SEFRIA™ Fentanyl Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its intended use.