(86 days)
Not Found
No
The summary describes a standard enzyme immunoassay for detecting methamphetamine in urine, relying on chemical reactions and optical density measurements. There is no mention of AI, ML, or any computational analysis beyond basic data processing for qualitative and semi-quantitative results.
No
This device is an in-vitro diagnostic device intended for the qualitative and semi-quantitative analysis of Methamphetamine in human urine. It is used to provide preliminary analytical test results for diagnosis, not for therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "This in-vitro diagnostic device is for prescription use only." This phrase directly indicates that the device is intended for diagnostic purposes.
No
The device is an in-vitro diagnostic device consisting of reagents (antibody/substrate and enzyme conjugate) and calibrators, which are physical components used in a laboratory setting with automated clinical chemistry analyzers. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in-vitro diagnostic device is for prescription use only."
- Intended Use: The device is intended for the "qualitative and semi-quantitative analysis of Methamphetamine in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Device Description: The description details the reagents and calibrators used in the assay, which are components of an in vitro diagnostic test.
- Performance Studies: The document describes performance studies conducted to evaluate the device's accuracy and reliability for its intended diagnostic use (e.g., precision, specificity, interference, method comparison).
- Predicate Devices: The mention of predicate devices (K093114 DRI® Methamphetamines Assay; K051088 LZI Multiple Analyte Drugs of Abuse Calibrators and Controls) which are also IVDs, further supports the classification of this device as an IVD.
N/A
Intended Use / Indications for Use
The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Methamphetamine 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, PCP and Oxazepan. The calibrators are designed for prescription use with immunoassays.
Product codes (comma separated list FDA assigned to the subject device)
LAF, DKB, DKZ
Device Description
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Methamphetamine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris 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 | Multi-Drug Calibrators
| Level 1 | Level 2 | Level 3 | Level 4
Benzoylecgonine | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL
Methamphetamine | 500ng/mL | 1000ng/mL | 1500ng/mL | 2000ng/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
Urine (human)
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)
The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Methamphetamine Urine Enzyme Immunoassay to the predicate:
-
Precision/ Cutoff Characterization/ Reproducibility:
- Study was performed for 20 days, 2 runs per day in duplicate on drug free urine (N=80) spiked with methamphetamine to concentrations 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.
- Instruments used: Beckman Coulter AU 400e.
- Qualitative Analysis (500ng/mL cutoff): At cutoff (500ng/mL), 41 Negative/39 Positive. At +25% and above, all 80 were Positive. From -25% and below, all 80 were Negative.
- Qualitative Analysis (1000ng/mL cutoff): At cutoff (1000ng/mL), 44 Negative/36 Positive. At +25% and above, all 80 were Positive. From -25% and below, all 80 were Negative.
- Semi-Quantitative Analysis (500ng/mL cutoff): At cutoff (500ng/mL), 35 Negative/45 Positive. At +25% and above, all 80 were Positive. From -25% and below, all 80 were Negative.
- Semi-Quantitative Analysis (1000ng/mL cutoff): At cutoff (1000ng/mL), 37 Negative/43 Positive. At +25% and above, all 80 were Positive. From -25% and below, all 80 were Negative.
-
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, in both the qualitative and semi-quantitative modes.
- Instrument used: Beckman Coulter AU 400e.
- Results for various structurally related compounds and their cross-reactivity percentages were provided for both 500ng/mL and 1000ng/mL cutoffs in qualitative and semi-quantitative modes.
-
Interference (Structurally unrelated compounds):
- Structurally unrelated compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free urine containing methamphetamine at ±25% of the cutoff.
- All potential interferents analyzed verified that assay performance is unaffected by externally ingested compounds.
- Instrument used: Beckman Coulter AU 400e.
- Results for a wide range of compounds were presented, showing Negative results for -25% cutoff and Positive results for +25% cutoff for both qualitative and semi-quantitative modes.
-
Interference (Endogenous compounds):
- Endogenous compounds were evaluated in qualitative and semi-quantitative modes by spiking the potential interferent into drug free urine containing methamphetamine at ±25% of the cutoff.
- All potential interferents analyzed verified that assay performance is unaffected by internally existing physiological conditions.
- Instrument used: Beckman Coulter AU 400e.
- Results for various endogenous compounds were presented, showing Negative results for -25% cutoff and Positive results for +25% cutoff for both qualitative and semi-quantitative modes.
-
Interference (Boric Acid):
- Boric Acid at a concentration of 1% w/v was evaluated in qualitative and semi-quantitative modes by spiking into drug free urine containing methamphetamine at ±25% and ±50% of the cutoff.
- Instrument used: Beckman Coulter AU 400e.
- At +25% cutoff (625ng/mL) for 500ng/mL cutoff, Boric Acid showed Negative results for both qualitative and semi-quantitative.
- At +25% cutoff (1250ng/mL) for 1000ng/mL cutoff, Boric Acid showed Negative for qualitative and Positive for semi-quantitative.
- At +50% cutoff (750ng/mL) for 500ng/mL cutoff, Boric Acid showed Negative for qualitative and N/A for semi-quantitative.
- At +50% cutoff (750ng/mL) for 1000ng/mL cutoff, Boric Acid showed Negative for both qualitative and semi-quantitative.
-
Interference (pH of urine):
- Device performance was tested using a range of urine pH values (3.0 to 11.0) with samples prepared in drug-free urine containing methamphetamine at ±25% of the cutoff.
- No positive or negative interference was observed.
- Instrument used: Beckman Coulter AU 400e.
-
Interference (Specific gravity of urine):
- Device performance was tested using a range of physiologically relevant urine specific gravity values (1.000 to 1.030) with samples prepared in drug-free urine containing methamphetamine at ±25% of the cutoff.
- No positive or negative interference was observed.
-
Linearity/ Recovery:
- A linearity study in semi-quantitative mode was conducted by spiking drug-free urine with a high concentration of methamphetamine.
- Pools were made by serial dilution from 200ng/mL to 2200ng/mL. Each pool was tested in triplicate.
- Instrument used: Beckman Coulter AU 400e.
- Recovery percentages ranged from 101.2% to 136.4%.
-
Method Comparison:
- Eighty unaltered, anonymous, and discarded clinical urine samples were analyzed with the candidate device on a Beckman Coulter AU 400e and verified by Mass Spectrometry (LC-MS/MS).
- Results were obtained in both qualitative and semi-quantitative modes.
- Instruments used: Beckman Coulter AU 400e and Agilent 6430 Liquid Chromatography Tandem Mass Spectrometer.
- Qualitative Assay Performance (500ng/mL cutoff): 40 positive and 40 negative by LC/MS validation. Test device showed 40 positive and 40 negative. Agreement was 100% for both positive and negative results across all concentration ranges tested (750ng/mL).
- Qualitative Assay Performance (1000ng/mL cutoff): 40 positive and 40 negative by LC/MS validation. Test device showed 40 positive and 40 negative. Agreement was 100% for both positive and negative results across all concentration ranges tested.
- Semi-Quantitative Assay Performance (500ng/mL cutoff): Test Device detected 40 positive (36 true positive, 4 false positive based on LC/MS >500ng/mL) and 39 negative (36 true negative, 3 false negative based on LC/MS 1000ng/mL) and 40 negative (36 true negative, 4 false negative based on LC/MS
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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
March 18, 2016
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST II 829 TOWNE CENTER DRIVE POMONA CA 91767
Re: K153693
Trade/Device Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay. Immunalysis Multi-drug Calibrators Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: II Product Code: LAF, DKB Dated: December 21, 2015 Received: December 23, 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 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
2
Indications for Use
510(k) Number (if known)
Device Name
Immunalysis Methamphetamine Urine Enzyme Immunalysis Multi-Drug Calibrators
Indications for Use (Describe)
The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. 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 Gas Chromatography/ Mass Spectrometry (GC-MS) or permitting laboratories to establish quality control procedures.
The Immunalysis Methamphetamine 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, PCP and Oxazepan. The calibrators are designed for prescription use with immunoassays.
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
-
- Manufacturer: Immunalysis Corporation
-
- Contact Name: Joseph Ginete
-
- Contact Title: Regulatory Affairs Specialist II
-
- Address: 829 Towne Center Drive Pomona, CA 91767
-
- Phone: (909) 482-0840
-
- Fax: (909) 482-0850
-
- Email: jginete(@immunalysis.com
-
- Summary prepared on: February 17, 2016
-
- B. Device Information
-
- Trade Name: Immunalysis Methamphetamine Urine Enzvme Immunoassay Immunalysis Multi-Drug Calibrators
-
- Common Name: Immunalysis Methamphetamine Urine Enzyme Immunoassay Immunalysis Multi-Drug Calibrators
-
C. Regulatory Information
-
- Device Classification: II
-
- Regulation Number: 21 CFR 862.3100 Enzyme Immunoassay,
Methamphetamine
21 CFR 862.3200 Clinical Toxicology Calibrator
-
- Panel: Toxicology(91)
-
- Product Code: DKZ
DKB
- D. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
-
- Predicate Device: DRI® Methamphetamines Assay LZI Multiple Analyte Drugs of Abuse Calibrators and Controls
-
- Predicate Company: Microgenics, Inc. Lin-Zhi International, Inc.
-
- Predicate K Number: K093114
-
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- E. Device Description
-
- The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Methamphetamine, glucose-6-phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes Methamphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris 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 | Multi-Drug Calibrators | |||
Level 1 | Level 2 | Level 3 | Level 4 | |
Benzoylecgonine | 150ng/mL | 300ng/mL | 500ng/mL | 1000ng/mL |
Methamphetamine | 500ng/mL | 1000ng/mL | 1500ng/mL | 2000ng/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
- The Immunalysis Methamphetamine Urine Enzyme Immunoassay is a 1. homogeneous enzyme immunoassay with a dual cutoff of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Methamphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Methamphetamine. 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 Methamphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC-MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical
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consideration and professional judgment should be applied to 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, Methamphetamine, 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 | Methamphetamine Assay K093114 | Immunalysis Methamphetamine Urine EIA |
---|---|---|
Intended Use | For the qualitative and semi-quantitative determination of the presence of Methamphetamine in human urine at a cutoff of 500ng/mL and 1000ng/mL | For the qualitative and semi-quantitative determination of the presence of Methamphetamine in human urine at a cutoff of 500ng/mL and 1000ng/mL |
Type of Product | Analytical Reagents | Analytical Reagents |
Measured Analytes | Methamphetamine and Amphetamine | Methamphetamine |
Test Matrix | Urine | Urine |
Cutoff Levels | 500ng/mL and 1000ng/mL of | |
Methamphetamine/Amphetamine | 500ng/mL and 1000ng/mL of | |
Methamphetamine | ||
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 | Monoclonal antibodies to | |
Methamphetamine and/or | ||
Amphetamine | Monoclonal antibody to Methamphetamine | |
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, methamphetamine, | |
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 |
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Table 2 LZI Multiple Analyte DAU Calibrators and Controls | ||||
---|---|---|---|---|
Analyte | Multiple Analyte Calibrators | |||
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 Methamphetamine 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 methamphetamine to concentrations 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 |
---|
500ng/mL cutoff test data results. |
Table 3 - Qualitative Analysis (for 500ng/mL cutoff) | |||
---|---|---|---|
Concentration (ng/mL) | % of cutoff | # of determinations | Result |
0 | -100% | 80 | 80 Negative |
125 | -75% | 80 | 80 Negative |
250 | -50% | 80 | 80 Negative |
375 | -25% | 80 | 80 Negative |
500 | Cutoff | 80 | 41 Negative/39 Positive |
625 | +25% | 80 | 80 Positive |
750 | +50% | 80 | 80 Positive |
875 | +75% | 80 | 80 Positive |
1000 | +100% | 80 | 80 Positive |
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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 | 44 Negative/36 Positive | |
1250 | +25% | 80 | 80 Positive | |
1500 | +50% | 80 | 80 Positive | |
1750 | +75% | 80 | 80 Positive | |
2000 | +100% | 80 | 80 Positive |
- b. The following is a summary table of the Qualitative Analysis for the 1000ng/mL cutoff test data results
- c. The following is a summary table of the Semi-Quantitative Analysis for the 500ng/mL cutoff test data results.
Table 5 - Semi-Quantitative Analysis (for 500ng/mL cutoff) | |||
---|---|---|---|
Concentration (ng/mL) | % of cutoff | # of determinations | Result |
0 | -100% | 80 | 80 Negative |
125 | -75% | 80 | 80 Negative |
250 | -50% | 80 | 80 Negative |
375 | -25% | 80 | 80 Negative |
500 | Cutoff | 80 | 35 Negative/45 Positive |
625 | +25% | 80 | 80 Positive |
750 | +50% | 80 | 80 Positive |
875 | +75% | 80 | 80 Positive |
1000 | +100% | 80 | 80 Positive |
- d. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/mL cutoff test data results.
Table 6 - Semi-Quantitative Analysis (for 1000ng/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 | 37 Negative/43 Positive |
1250 | +25% | 80 | 80 Positive |
1500 | +50% | 80 | 80 Positive |
1750 | +75% | 80 | 80 Positive |
2000 | +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, in both the qualitative and semi-
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quantitative modes. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The qualitative result summary table for the 500ng/mL cutoff is outlined below:
Table 7 - Structurally Related Compounds (for 500 ng/mL cutoff) - Qualitative | |||
---|---|---|---|
Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
(+) Methamphetamine | 500 | Positive | 100.00 |
(-) Methamphetamine | 90,000 | Positive | 0.56 |
(+) Amphetamine | 20,000 | Positive | 2.50 |
(-) Amphetamine | 900,000 | Positive | 0.06 |
Methylenedioxyamphetamine (MDA) | 18,000 | Positive | 2.78 |
Methoxyamphetamine (PMA) | 15,000 | Positive | 3.33 |
Methylenedioxymethamphetamine (MDMA) | 800 | Positive | 62.50 |
MDEA | 3,000 | Positive | 16.67 |
Fenfluramine | 7,000 | Positive | 7.14 |
(+) Pseudoephedrine | 75,000 | Positive | 0.67 |
(-) Pseudoephedrine | 300,000 | Positive | 0.17 |
(-) Ephedrine | 65,000 | Positive | 0.77 |
(+) Ephedrine | 1,000,000 | Negative | Negative |
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- b. The following is a summary table of the Boric Acid for the 1,000ng/mL cutoff results:
Table 16 – Boric Acid (for 1000ng/mL cutoff) | ||||||
---|---|---|---|---|---|---|
Compound | Concentration | |||||
Tested | ||||||
(ng/mL) | -25% Cutoff | |||||
(750ng/mL) | +25% Cutoff | |||||
(1250ng/mL) | ||||||
Qualitative | Semi- | |||||
Quantitative | Qualitative | Semi- | ||||
Quantitative | ||||||
Boric Acid | 1% w/v | Negative | Negative | Negative | Positive |
- c. The following is a summary table of the Boric Acid for the 500ng/mL cutoff results:
Table 17 – Boric Acid (for 500ng/mL cutoff) | ||||||
---|---|---|---|---|---|---|
Compound | Concentration | |||||
Tested | ||||||
(ng/mL) | -50% Cutoff | |||||
(250ng/mL) | +50% Cutoff | |||||
(750ng/mL) | ||||||
Qualitative | Semi- | |||||
Quantitative | Qualitative | Semi- | ||||
Quantitative | ||||||
Boric Acid | 1% w/v | Negative | Negative | Negative | N/A |
- d. The following is a summary table of the Boric Acid for the 1,000ng/mL cutoff results:
Table 18 – Boric Acid (for 1000ng/mL cutoff) | ||||||
---|---|---|---|---|---|---|
Compound | Concentration | |||||
Tested | ||||||
(ng/mL) | -50% Cutoff | |||||
(250ng/mL) | +50% Cutoff (750ng/mL) | |||||
Qualitative | Semi- | |||||
Quantitative | Qualitative | Semi- | ||||
Quantitative | ||||||
Boric Acid | 1% w/v | Negative | Negative | Negative | Negative |
- Interference To evaluate potential interference from the pH of urine, device 6. performance in the qualitative and semi-quantitative modes 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 methamphetamine at ±25% of the cutoff. No positive or negative interference was observed at urine pH values ranging from 3.0 to 11.0 for each test mode. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The following is a summary table of the effect of pH results for the 500ng/mL cutoff:
Table 19 - Effect of pH (for 500ng/mL cutoff) | |||||
---|---|---|---|---|---|
Test Parameter | Value | -25% Cutoff (375ng/mL) | +25% Cutoff (625ng/mL) | ||
Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | ||
pH | 3.0 | Negative | Negative | Positive | Positive |
pH | 4.0 | Negative | Negative | Positive | Positive |
pH | 5.0 | Negative | Negative | Positive | Positive |
pH | 6.0 | Negative | Negative | Positive | Positive |
pH | 7.0 | Negative | Negative | Positive | Positive |
pH | 8.0 | Negative | Negative | Positive | Positive |
pH | 9.0 | Negative | Negative | Positive | Positive |
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Table 19 - Effect of pH (for 500ng/mL cutoff) | |||||
---|---|---|---|---|---|
Test Parameter | Value | -25% Cutoff | +25% Cutoff | ||
(375ng/mL) | (625ng/mL) | ||||
Qualitative | Semi- | Qualitative | Semi- | ||
Quantitative | Quantitative | ||||
pH | 10.0 | Negative | Negative | Positive | Positive |
pH | 11.0 | Negative | Negative | Positive | Positive |
b. The following is a summary table of the effect of pH results for the 1,000ng/mL cutoff:
Table 20 - Effect of pH (for 1000ng/mL cutoff) | |||||
---|---|---|---|---|---|
Test Parameter | Value | -25% Cutoff | |||
(750ng/mL) | +25% Cutoff | ||||
(1250ng/mL) | |||||
Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative | ||
pH | 3.0 | Negative | Negative | Positive | Positive |
pH | 4.0 | Negative | Negative | Positive | Positive |
pH | 5.0 | Negative | Negative | Positive | Positive |
pH | 6.0 | Negative | Negative | Positive | Positive |
pH | 7.0 | Negative | Negative | Positive | Positive |
pH | 8.0 | Negative | Negative | Positive | Positive |
pH | 9.0 | Negative | Negative | Positive | Positive |
pH | 10.0 | Negative | Negative | Positive | Positive |
pH | 11.0 | Negative | Negative | Positive | Positive |
-
- Interference To evaluate potential interference from the specific gravity of urine, device performance in the qualitative and semi-quantitative modes was tested using a range of physiologically relevant urine specific gravity values (1.000, 1.002, 1.005, 1.010, 1.015, 1.020, 1.025 and 1.030). All test samples were prepared in drug free urine containing methamphetamine at ±25% of the cutoff. No positive or negative interference was observed at urine specific gravity values ranging from 1.000 to 1.030 for each test mode.
- a. The following is a summary table of the effect of specific gravity results for 500ng/mL cutoff:
Table 21 - Effect of Specific Gravity (for 500ng/mL cutoff) | |||||
---|---|---|---|---|---|
Test Parameter | Value | -25% Cutoff | |||
(375ng/mL) | +25% Cutoff | ||||
(625ng/mL) | |||||
Qualitative | Semi- | Qualitative | Semi- | ||
Quantitative | Quantitative | ||||
Specific Gravity | 1.000 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.002 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.005 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.010 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.015 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.020 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.025 | Negative | Negative | Positive | Positive |
Specific Gravity | 1.030 | Negative | Negative | Positive | Positive |
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| | | -25% Cutoff
(750ng/mL) | | +25% Cutoff
(1250ng/mL) | |
|------------------|-------|---------------------------|-------------------|----------------------------|-------------------|
| Test Parameter | Value | Qualitative | Semi-Quantitative | Qualitative | Semi-Quantitative |
| Specific Gravity | 1.000 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.002 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.005 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.010 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.015 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.020 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.025 | Negative | Negative | Positive | Positive |
| Specific Gravity | 1.030 | Negative | Negative | Positive | Positive |
- b. The following is a summery table of the effect of specific gravity results for 1 000ng/mI a
-
- Linearity/ Recovery A linearity study in the semi-quantitative mode was conducted by spiking a drug free urine pool with a high concentration of methamphetamine as a high value specimen. Additional pools were made by serially diluting the high value specimen with drug free urine to achieve concentrations ranging from 200ng/mL to 2200ng/mL. Each pool was tested in triplicate to calculate the mean concentration values that were used to calculate drug recovery. The instrument used for this test was a Beckman Coulter AU 400e. a. The following is a summary table of the linearity/recovery:
Table 23 - Linearity/ Recovery | ||
---|---|---|
Expected Concentration (ng/mL) | Mean Concentration (ng/mL) | Recovery (%) |
200 | 272.7 | 136.4 |
400 | 436.8 | 109.2 |
600 | 674.6 | 112.4 |
800 | 830.0 | 103.8 |
1000 | 1107.6 | 110.8 |
1200 | 1247.0 | 103.9 |
1400 | 1481.2 | 105.8 |
1600 | 1711.5 | 107.0 |
1800 | 1917.4 | 106.5 |
2000 | 2080.7 | 104.0 |
2200 | 2226.4 | 101.2 |
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-
- Method Comparison Eighty unaltered, anonymous and discarded clinical urine samples obtained from clinical testing laboratories were analyzed for methamphetamine with the candidate test device on a Beckman Coulter AU 400e clinical chemitrsy analyzer and verified by Mass Spectrometry (LC-MS/MS). Results were obtained in both qualitative and semi-quantitative modes. The instruments used for this test was a Beckman Coulter AU 400e and an Agilent 6430 Liquid Chromatography Tandem Mass Spectrometer.
- a. The following is a comparison table of qualitative assay performance for the 500ng/mL cutoff:
Table 24 - Method Comparison (for 500ng/mL cutoff) - Qualitative
LC/MS Confirmation | |||
---|---|---|---|
(+) | (-) | ||
Test | |||
Device | (+) | 40 | 0 |
(-) | 0 | 40 |
b. The following is a summary table of qualitative assay performance for the 500ng/mL cutoff:
Table 25 - Assay Performance verified by LC/MS – 500ng/mL Cutoff | |||||
---|---|---|---|---|---|
Type | 750 ng/mL | Agreement (%) | |||
Qualitative/ Positive | 0 | 0 | 4 | 36 | 100 |
Qualitative/ Negative | 36 | 4 | 0 | 0 | 100 |
c. The following is a comparison table of qualitative assay performance for the 1,000ng/mL cutoff:
Table 26 - Method Comparison (for 1000ng/mL cutoff) - Qualitative
LC/MS Confirmation | ||
---|---|---|
(+) | (-) | |
Test | ||
Device | ||
(+) | 40 | 0 |
Test | ||
Device | ||
(-) | 0 | 40 |
d. The following is a summary table of qualitative assay performance for the 1,000ng/mL
Table 27 - Assay Performance verified by LC/MS – 1000ng/mL Cutoff | |||||
---|---|---|---|---|---|
Type | Methamphetamine Concentration | Agreement | |||
(%) | |||||
Qualitative/ Positive | 1500 ng/mL | 100 | |||
Qualitative/ Negative | 36 | 4 | 0 | 0 | 100 |
0 | 0 | 16 | 24 |
e. The following is a comparison table of semi-quantitative assay performance for the 500ng/mL cutoff:
Table 28 - Method Comparison (for 500ng/mL cutoff) - Semi-Quantitative
LC/MS Confirmation | |||
---|---|---|---|
(+) | (-) | ||
Test | |||
Device | (+) | 40 | 1 |
(-) | 0 | 39 |
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f. The following is a summary table of semi-quantitative assay performance for the 500ng/mL cutoff:
| Type | Methamphetamine Concentration | | | Agreement
(%) | |
|------------------------------|-------------------------------|-----------------|-----------------|------------------|-----|
| | 750 ng/mL | |
| Semi-Quantitative/ Positive | 0 | 1 | 4 | 36 | 98 |
| Semi-Quantitative / Negative | 36 | 3 | 0 | 0 | 100 |
g. The following is a summary table of semi-quantitative discordant results for the 500ng/mL cutoff:
Sample ID | In-House ID | Semi-Quantitative Results 500ng Cutoff | LC/MS Confirmation |
---|---|---|---|
Table 30 - Discordant Result Summary – 500ng/mL Cutoff – Semi-Quantitative | Value | Result | |
358433ZA | 16559 | 544.9 | Positive |
494 |
h.The following is a comparison table of semi-quantitative assay performance for the 1,000ng/mL cutoff:
Table 31 - Method Comparison (for 1000ng/mL cutoff) - Semi-Quantitative
LC/MS Confirmation | |||
---|---|---|---|
(+) | (-) | ||
Test | |||
Device | (+) | 39 | 0 |
(-) | 1 | 40 |
i. The following is a summary table of semi-quantitative assay performance for the 1,000ng/mL cutoff:
| Type | Methamphetamine Concentration | | | | Agreement
(%) |
|------------------------------|-------------------------------|-----------------|-------------------|--------------|------------------|
| | 1500 ng/mL | |
| Semi-Quantitative/ Positive | 0 | 0 | 3 | 36 | 100 |
| Semi-Quantitative / Negative | 36 | 4 | 1 | 0 | 98 |
j. The following is a summary table of semi-quantitative discordant results for the 1000ng/mL cutoff
Table 33 - Discordant Result Summary – 1000ng/mL Cutoff – Semi-Quantitative | ||||
---|---|---|---|---|
Sample ID | In-House ID | Semi-Quantitative Results 1000ng Cutoff | LC/MS Confirmation | |
Value | Result | |||
358429ZA | 16597 | 998.5 | Negative | 1017 |
- Immunalysis Multi-Drug Calibrators Analytical Performance
- a. Traceability all components of the calibrators have been traced to a commercially available methamphetamine solution.
- b.Closed Vial Stability (Accelerated) A closed vial stability study was performed at 25°C 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.
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- c. Open Vial Stability An open vial stability study was performed at 5℃ 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 Methamphetamine Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.