(189 days)
Not Found
No
The device description and performance studies describe a standard enzyme immunoassay and calibrators, with no mention of AI or ML algorithms for data analysis or interpretation. The analysis is based on chemical reactions and comparison to known calibrator concentrations.
No
Explanation: This device is an in-vitro diagnostic immunoassay kit used to detect Benzodiazepines in human urine, which provides analytical test results rather than providing therapy to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in-vitro device is for prescription use only." The device is intended for the qualitative and semi-quantitative analysis of Benzodiazepines in human urine, which is a diagnostic purpose.
No
The device is an in-vitro diagnostic assay kit consisting of reagents and calibrators, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states, "This in-vitro device is for prescription use only." It also describes the assay's purpose as the "qualitative and semi-quantitative analysis of Benzodiazepines in human urine," which is a diagnostic test performed on a biological sample outside of the body.
- Device Description: The description details the components of the assay kit, which are reagents used to perform a diagnostic test.
- Immunalysis Multi-Drug Calibrators: The description of the calibrators also states they are "intended for in vitro diagnostic use."
- Performance Studies: The document describes various performance studies (Precision, Specificity, Interference, Linearity, Method Comparison) which are typical evaluations for an IVD to demonstrate its analytical performance.
- Key Metrics: The presentation of metrics like agreement percentages with a confirmatory method (LC/MS) is standard for demonstrating the performance of an IVD.
- Predicate Device(s): The mention of predicate devices with K numbers (K930529, K051088) indicates that this device is being compared to previously cleared IVDs.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Immunalysis Benzodiazepines 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 Benzodiazepines in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxazepam. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Benzodiazepines 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. 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 Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and Oxazepam. The calibrators are designed for prescription use with immunoassays.
Product codes (comma separated list FDA assigned to the subject device)
JXM, DKB
Device Description
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Benzodiazepine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Benzodiazepines derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative.
- All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. 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 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators is summarized as follows:
Table 1 Immunalysis Multi-Drug Calibrators
Analyte, Level 1, Level 2, Level 3, Level 4
Benzoylecgonine, 150ng/mL, 300ng/mL, 500ng/mL, 1000ng/mL
Morphine, 100ng/mL, 300ng/mL, 500ng/mL, 1000ng/mL
PCP, 12.5ng/mL, 25ng/mL, 50ng/mL, 100ng/mL
Oxazepam, 100ng/mL, 200ng/mL, 500ng/mL, 1000ng/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
Not Found
Intended User / Care Setting
laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Precision/ Cutoff Characterization/ Reproducibility:
Study Type: Precision/Cutoff Characterization
Sample Size: 80 (drug free urine samples)
Data Source: Spiked with oxazepam to concentrations of ±25%, ±50%, ±75%, and ±100% of the cutoff. Spiked concentrations confirmed by mass spectrometry (MS).
Key Results: Verified that the cutoff serves as a boundary between negative and positive interpretation of a qualitative result.
Qualitative Analysis (for 200ng/mL cutoff):
0 ng/mL: 80 Negative
50 ng/mL: 80 Negative
100 ng/mL: 80 Negative
150 ng/mL: 80 Negative
200 ng/mL (Cutoff): 37 Neg / 43 Pos
250 ng/mL: 80 Positive
300 ng/mL: 80 Positive
350 ng/mL: 80 Positive
400 ng/mL: 80 Positive
Semi-Quantitative Analysis (for 200ng/mL cutoff):
0 ng/mL: 80 Negative
50 ng/mL: 80 Negative
100 ng/mL: 80 Negative
150 ng/mL: 80 Negative
200 ng/mL (Cutoff): 34 Neg / 46 Pos
250 ng/mL: 80 Positive
300 ng/mL: 80 Positive
350 ng/mL: 80 Positive
400 ng/mL: 80 Positive
-
Specificity and Cross-Reactivity:
Study Type: Specificity and Cross-Reactivity
Data Source: Various Benzodiazepines or structurally similar compounds spiked into drug free urine at levels yielding a result equivalent to the cutoff.
Key Results: Verified assay performance relative to the ability of the device to exclusively determine certain drugs, in both qualitative and semi-quantitative modes. (Detailed tables of cross-reactivity percentages for various compounds are provided in Tables 5 and 6). -
Interference:
Study Type: Interference (Structurally unrelated compounds and Endogenous compounds)
Data Source: Structurally unrelated compounds and endogenous compounds spiked into drug free urine containing oxazepam at ±25% of the cutoff. Boric acid interference also evaluated at 1% w/v at ±25% and ±50% of cutoff. pH levels from 3.0 to 11.0 and specific gravity values from 1.000 to 1.030 were tested.
Key Results: All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds or internally existing physiological conditions, with the exception of Boric Acid. Boric Acid at 1% w/v was found to cause false negative results at ±25% and ±50% ng/mL of the cutoff in both qualitative and semi-quantitative modes. No positive or negative interference was observed at urine pH values ranging from 3.0 to 11.0 or specific gravity values ranging from 1.000 to 1.030. -
Linearity/ Recovery:
Study Type: Linearity/ Recovery (semi-quantitative mode)
Data Source: Drug free urine pool spiked with high oxazepam concentration, then serially diluted to achieve concentrations from 100ng/mL to 1100ng/mL. Each pool tested in triplicate.
Key Results: Values are provided for Expected Concentration, Mean Concentration, and Recovery (%). Recovery percentages generally range from 94.2% to 106.8%. -
Method Comparison:
Study Type: Method Comparison
Sample Size: 80 (unaltered, anonymous, discarded clinical urine samples)
Data Source: Clinical urine samples analyzed with the subject device (Beckman Coulter AU 400e) and LC/MS.
Key Results: Comparison tables for both qualitative and semi-quantitative assay performance (Tables 14-16) against LC/MS confirmation.
Qualitative Assay Performance (200ng/mL Cutoff):
Test Device (+) with LC/MS Confirmation (+): 42
Test Device (+) with LC/MS Confirmation (-): 0
Test Device (-) with LC/MS Confirmation (+): 1
Test Device (-) with LC/MS Confirmation (-): 43
Agreement (%):
Qualitative/Positive: 100% (42/42)
Qualitative/Negative: 98% (43/44)
Semi-Quantitative Assay Performance (200ng/mL Cutoff):
Test Device (+) with LC/MS Confirmation (+): 42
Test Device (+) with LC/MS Confirmation (-): 0
Test Device (-) with LC/MS Confirmation (+): 1
Test Device (-) with LC/MS Confirmation (-): 43
Agreement (%):
Semi-Quantitative/Positive: 100% (42/42)
Semi-Quantitative/Negative: 98% (43/44)
- Immunalysis Multi-Drug Calibrators Analytical Performance:
Study Type: Traceability, Closed Vial Stability (Accelerated), Open Vial Stability, Value Assignment.
Key Results:
Traceability: All components of calibrators traced to commercially available oxazepam solution.
Closed Vial Stability: Supported an initial expiration date of 12 months after testing on LC/MS. Real-time studies ongoing.
Open Vial Stability: Supported an initial open vial expiration date of 60 days.
Value Assignment: Calibrators manufactured and tested by mass spectrometry. Negative calibrator verified drug free. Non-zero calibrators prepared by spiking known concentrations of oxazepam. Values assigned once MS results within acceptable ranges.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Qualitative Assay Performance (200ng/mL Cutoff):
Agreement (%):
Qualitative/Positive: 100
Qualitative/Negative: 98
Semi-Quantitative Assay Performance (200ng/mL Cutoff):
Agreement (%):
Semi-Quantitative/Positive: 100
Semi-Quantitative/Negative: 98
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
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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 Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle with three heads in profile, facing right. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2016
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DR POMONA CA 91767
Re: K151771
Trade/Device Name: Immunalysis Benzodiazepines Urine Enzyme Immunoassay. Immunalysis Multi-drug Calibrators Regulation Number: 21 CFR 862.3170 Regulation Name: Benzodiazepine test system Regulatory Class: II Product Code: JXM, DKB Dated: December 24, 2015 Received: December 28, 2015
Dear Mr. 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 (OS) 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,
Courtney
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)
Device Name
Immunalysis Benzodiazepines Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators
Indications for Use (Describe)
The Immunalysis Benzodiazepines 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 Benzodiazepines in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxazepam. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Benzodiazepines 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. 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 Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine and Oxazepam. The calibrators are designed for prescription use with immunoassays.
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
Image /page/3/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is centered in the image. The red background is a solid color and there are no other objects in the image.
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: | December 24, 2015 |
- B. Device Information
-
- Trade Name: Immunalysis Benzodiazepine Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators
-
- Common Name: Immunalysis Benzodiazepine Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators
-
C. Regulatory Information
-
- Device Classification:
-
- Regulation Number: 21 CFR862.3170 Benzodiazepine Test System
II
21 CFR 862.3200 Clinical Toxicology Calibrator
-
- Panel: Toxicology(91)
- JXM 4. Product Code:
DKB
- D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
| 1. | Predicate Device: | DRI® Benzodiazepines Assay
LZI Multiple Analyte Drugs of Abuse Calibrators
and Controls |
|----|---------------------|-----------------------------------------------------------------------------------------------|
| 2. | Predicate Company: | Microgenics
Lin-Zhi International, Inc. |
| 3. | Predicate K Number: | K930529
K051088 |
4
- E. Device Description
-
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Benzodiazepine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in HEPES buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Benzodiazepines derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in HEPES buffer with Sodium Azide as a preservative.
-
- All of the Immunalysis Multi-Drug Calibrators are liquid and ready to use. 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 are prepared by spiking known concentrations of drug analyte into the negative calibrator matrix. These five calibrators (negative, Level 1, 2, 3 and 4) are sold as individual bottles. The concentration of drug analyte in the corresponding calibrators is summarized as follows:
| Table 1 Immunalysis Multi-Drug Calibrators | ||||
|---|---|---|---|---|
| Analyte | Level 1 | Level 2 | Level 3 | Level 4 |
| Benzoylecgonine | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL |
| Morphine | 100ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL |
| PCP | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL |
| Oxazepam | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL |
F. Intended Use
-
- Immunalysis Benzodiazepine Urine Enzyme Immunoassay
The Immunalysis Benzodiazepine 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 Benzodiazepine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxazepam. This in-vitro device is for prescription use only.
- Immunalysis Benzodiazepine Urine Enzyme Immunoassay
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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Benzodiazepine 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. GC-MS or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to
5
Image /page/5/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and have a slight 3D effect, making them stand out from the background. The word is centered and fills most of the frame, making it the focal point of the image. The red background is a solid color, providing a strong contrast to the white letters.
any drug of abuse test result, particularly when preliminary positive results are used.
-
- Immunalysis Multi-Drug Calibrators
The Immunalysis Multi-Drug Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Morphine, PCP and Oxazepam. The calibrators are designed for prescription use with immunoassays.
- Immunalysis Multi-Drug Calibrators
-
G. Comparison of the new device with the predicate device
| Item | Benzodiazepines Assay K930529 | Immunalysis Benzodiazepines Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi-quantitative determination of the presence of Benzodiazepines in human urine at a cutoff of 200ng/mL | For the qualitative and semi-quantitative determination of the presence of Benzodiazepines in human urine at a cutoff of 200ng/mL |
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured | ||
| Analytes | Benzodiazepine | Benzodiazepine |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 200ng/mL of Oxazepam | 200ng/mL of Oxazepam |
| Test System | Homogeneous Enzyme | |
| Immunoassay | Homogeneous Enzyme Immunoassay | |
| Materials | Liquid Ready-to-Use Two Reagent Assay (R1 and R2) | Antibody/Substrate Reagents and Enzyme Labeled Conjugate |
| Mass | ||
| Spectroscopy | ||
| Confirmation | Required for preliminary positive analytical results | Required for preliminary positive analytical results |
| Antibody | Sheep Polyclonal to Benzodiazepine | Monoclonal antibody to Benzodiazepines |
| Storage | 2 – 8°C until expiration date | 2 - 8°C until expiration date |
| Item | LZI Multiple Analyte K051088 | Immunalysis Multi-Drug Calibrator |
|---|---|---|
| Analyte | benzoylecgonine, d- | |
| methamphetamine, methadone, | ||
| morphine, oxazepam, | ||
| secobarbital, phencyclidine, | ||
| propoxyphene | benzoylecgonine, morphine, PCP, oxazepam | |
| Matrix | Urine | Urine |
| Calibrator Levels | 5 Levels – See Table 2 Below | 5 Levels (Negative and Level 1, 2, 3 and 4) - |
| See Device Description Table 1 | ||
| Storage | 2 – 8°C until expiration date | 2 - 8°C until expiration date |
6
Image /page/6/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters with a drop shadow. The word is set against a red background. The background is shaped like a rounded rectangle or a banner.
| Table 2 LZI Multiple Analyte DAU Calibrators and Controls | ||||
|---|---|---|---|---|
| Multiple Analyte Calibrators | ||||
| Analyte | Low | Cutoff | Intermediate | High |
| d-Methamphetamine | 250ng/mL | 500ng/mL | 750ng/mL | 1000ng/mL |
| Morphine | 1000ng/mL | 2000ng/mL | 4000ng/mL | 5000ng/mL |
| Phencyclidine | 12.5ng/mL | 25ng/mL | 50ng/mL | 100ng/mL |
| Benzoylecgonine | 75ng/mL | 150ng/mL | 300ng/mL | 1000ng/mL |
| Oxazepam | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL |
| Secobarbital | 100ng/mL | 200ng/mL | 500ng/mL | 1000ng/mL |
| Propoxyphene | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL |
| Methadone | 150ng/mL | 300ng/mL | 600ng/mL | 1000ng/mL |
- H. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Benzodiazepines Urine Enzyme Immunoassay to the predicate
-
- Precision/ Cutoff Characterization/ Reproducibility Precision/Cutoff Characterization - Study was performed for 20 days, 2 runs per day in duplicate on drug free urine (N=80) spiked with oxazepam to concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. 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. The instruments used for this was Beckman Coulter AU 400e.
- a. The following is a summary table of the Qualitative Analysis for the 200ng/mL cutoff test data results.
-
| Table 3 - 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 | 37 Neg / 43 Pos |
| 250 | +25% | 80 | 80 Positive |
| 300 | +50% | 80 | 80 Positive |
| 350 | +75% | 80 | 80 Positive |
| 400 | +100% | 80 | 80 Positive |
7
Image /page/7/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The letters are bold and have a slight 3D effect, with a shadow that makes them stand out from the background. The overall effect is a simple, eye-catching design.
| Table 4 - 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 | 34 Neg / 46 Pos |
| 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.
-
- Specificity and Cross-Reactivity Various Benzodiazepines or 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, in both the qualitative and semi-quantitative modes. The instrument used for this test was a Beckman Coulter AU 400e.
| ucturelly Roloted Compounds (for 200 ng/m] cutoff) - Quelitotive | |
|---|---|
| below: | |
| a. The qualitative result summary table for the 200ng/mL cutoff is outlined | |
| Table 5 - Structurally Related Compounds (for 200 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| Oxazepam | 200 | POS | 100.0 |
| Alpha-hydroxyalprazolam | 110 | POS | 181.8 |
| Alprazolam | 120 | POS | 166.7 |
| 7-Aminoclonazepam | 100,000 | NEG | 300 ng/mL |
| Qualitative/ | |||
| Positive | 0 | 0 | 4 |
| Qualitative/ | |||
| Negative | 36 | 7 | 1 |
c. The following is a comparison table of semi-quantitative assay performance for the 200ng/mL cutoff:
Table 16 - Method Comparison (for 200ng/mL cutoff) - Semi-Quantitative LC/MS Confirmation
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 42 | 0 |
| (-) | 1 | 43 |
15
Image /page/15/Picture/0 description: The image shows the word "IMMUNALYSIS" in white letters on a red background. The word is written in all capital letters and is bolded. The background is a solid red color, and the letters are slightly blurred.
| Type | Benzodiazepines Concentration | Agreement (%) | |||
|---|---|---|---|---|---|
| 300 ng/mL | |||||
| Semi-Quantitative/ Positive | 0 | 0 | 4 | 38 | 100 |
| Semi-Quantitative / Negative | 36 | 7 | 1 | 0 | 98 |
- d. The following is a summary table of semi-quantitative assay performance for the 200ng/mI_cutoff.
6. Immunalysis Multi-Drug Calibrators Analytical Performance
- a. Traceability all components of the calibrators have been traced to a commercially available oxazepam solution.
- b.Closed Vial Stability (Accelerated) A closed vial stability study was performed at 25℃ to establish the initial vial expiration dating. All calibrator levels (1, 2, 3, and 4) were within specifications for Day 0, 8, 16, 24, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. The stability study supported an initial expiration date of 12 months after testing on LC/MS. Real time stability studies are ongoing.
- c. Open Vial Stability An open vial stability study was performed at 5°C to establish the initial open vial expiration dating on LC/MS. All calibrator levels (1, 2, 3, and 4) were within specifications for Day 0, 19, 26, 33, 41, and 60. This stability study supported an initial open vial expiration date of 60 days.
- d. Value Assignment Calibrators are manufactured and are tested by mass spectrometry. The negative calibrator is a processed, drug free urine matrix. The standard 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 oxazepam in the negative calibrator matrix. If any of the analytes are not of the acceptable range, then the calibrator is adjusted and re-tested. Values are assigned to the calibrators once the mass spectrometry results are within the acceptable ranges.
- I. Proposed Labeling
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10
- J. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Benzodiazepines Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.