(58 days)
Not Found
No
The description focuses on a homogeneous enzyme immunoassay and its chemical components, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in-vitro diagnostic test intended for the qualitative and semi-quantitative analysis of Amphetamine in human urine. It is used to detect the presence of substances, not to provide therapy or treatment.
Yes
Explanation: The device is intended for the qualitative and semiquantitative analysis of Amphetamine in human urine, which is a diagnostic purpose to detect the presence of substances in the body.
No
The device is a homogeneous enzyme immunoassay kit, which is a chemical reagent-based in-vitro diagnostic device, not a software-only medical device.
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 device is for prescription use only."
- Nature of the Test: The device performs a test on a biological sample (human urine) in vitro (outside the body) to detect the presence of a substance (Amphetamine). This is the core definition of an in vitro diagnostic device.
- Purpose: The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine. This analysis is performed to provide information about a person's health status or condition (in this case, the presence of Amphetamine).
- Components: The device consists of reagents (antibody/substrate and enzyme conjugate) designed to react with components in the urine sample to produce a measurable signal. This is typical of IVD assays.
- Performance Studies: The document describes various performance studies (Precision, Specificity, Interference, Linearity, Method Comparison, Stability) which are standard for demonstrating the analytical performance of an IVD.
- Comparison to Predicate Devices: The document lists predicate devices, which are other legally marketed IVDs that the current device is being compared to for regulatory purposes.
All these factors clearly indicate that the Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/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 Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Control materials in Immunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DLJ, LAS
Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Amphetamine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes amphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The amphetamine calibrator and controls consist of dual cutoff calibrators at 500ng/mL and 1000ng/mL, a control set containing a LOW control at 375ng/mL and a HIGH control at 625ng/mL for the 500ng/mL cutoff and a LOW control at 750ng/mL and HIGH control at 1250ng/mL for the 1000ng/mL cutoff, and a calibrator set containing a negative calibrator, a Level 1 calibrator at 500ng/mL, a Level 2 calibrator at 1000ng/mL, a Level 3 calibrator at 1500ng/mL, and a Level 4 calibrator at 2000ng/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 Study: Performed for 20 days, 2 runs per day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result and that the product performance produced the same value during repeated measurements.
- 500 ng/mL cutoff: At cutoff (500 ng/mL), results were 48 Negative / 32 Positive. At +25% (625 ng/mL) and higher, all 80 determinations were positive. At -25% (375 ng/mL) and lower, all 80 determinations were negative.
- 1000 ng/mL cutoff: At cutoff (1000 ng/mL), results were 47 Negative / 33 Positive. At +25% (1250 ng/mL) and higher, all 80 determinations were positive. At -25% (750 ng/mL) and lower, all 80 determinations were negative.
- Specificity and Cross-Reactivity: Structurally similar compounds were spiked into drug free urine at levels that would yield a result equivalent to the cutoffs. The study verified assay performance regarding the ability of the device to exclusively determine certain drugs.
- 500 ng/mL cutoff (Qualitative and Semi-Quantitative): (+) Amphetamine showed 100.0% cross-reactivity. Other compounds showed varying degrees of cross-reactivity or were N.D. (
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
IMMUNALYSIS CORPORATION JOSEPH GINETE REGULATORY AFFAIRS SPECIALIST 829 TOWNE CENTER DRIVE POMONA CA 91767
February 6, 2015
Re: K143500
Trade/Device Name: Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DLJ, LAS Dated: December 9, 2014 Received: December 10, 2014
Dear Mr. Joseph Ginete:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -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) K143500
Device Name
Immunalysis Amphetamine Urine Enzyne Immunalysis Amphetamine Urine Calibrators, Immunalysis Amphetamine Urine Control Set
Indications for Use (Describe)
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit is a homogeneous enzyme immunoassay with dual cutoffs of 500 ng/mL and 1000 ng/mL. The assay is intended for use in laboratories for the qualitative and semiquantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Amphetamine Urine Enzyme Immunoassay Kit provides only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC-MS) or Liquid Chromatography/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 Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Control materials in Immunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay. for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| 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: | January 27, 2015 |
| B. | Device Information | |
| 1. | Trade Name: | Immunalysis Amphetamine Urine Enzyme Immunoassay |
| Immunalysis Amphetamine Urine Controls | ||
| Immunalysis Amphetamine Urine Calibrators | ||
| 2. | Common Name: | Immunalysis Amphetamine Urine Enzyme Immunoassay |
| Immunalysis Amphetamine Urine Controls | ||
| Immunalysis Amphetamine Urine Calibrators | ||
| 3. | Device Classification: | II |
| 4. | Regulation Number: | CFR 862.3100 Enzyme Immunoassay, Amphetamine |
| CFR 862.3200 Calibrators, Drug Specific | ||
| CFR 862.3280 Drug Specific Control Materials | ||
| 5. | Panel: | Toxicology(91) |
| 6. | Product Code: | DKZ |
| DLJ | ||
| LAS |
4
IMMUNALYSIS
C. Legally Marketed Device to Which We are Claiming Equivalence (807.92(A)(3))
| 1. Predicate Device: | VITROS® Chemistry Products AMPH Reagent
VITROS® Chemistry Products Calibrator Kit 26
VITROS® Chemistry Products FS Calibrator 1
VITROS® Chemistry Products DAT Performance
Verifiers I, II, III, IV and V |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Predicate Company: | Ortho-Clinical Diagnostics, Inc |
| 3. Predicate K Number: | K062077 |
D. Device Description
The assay consists of antibody/ substrate reagent and enzyme conjugate reagent. The antibody/ substrate reagent includes monoclonal antibodies to Amphetamine, glucose-6phosphate (G6P) and nicotinamide adenine dinucleotide (NAD) in Tris buffer with Sodium Azide as a preservative. The enzyme conjugate reagent includes amphetamine derivative labeled with glucose-6-phosphate dehydrogenase (G6PDH) in Tris buffer with Sodium Azide as a preservative. Calibrators and controls are sold separately. Reagents are liquid, ready to use
The amphetamine calibrator and controls consist of dual cutoff calibrators at 500ng/mL and 1000ng/mL, a control set containing a LOW control at 375ng/mL and a HIGH control at 625ng/mL for the 500ng/mL cutoff and a LOW control at 750ng/mL and HIGH control at 1250ng/mL for the 1000ng/mL cutoff, and a calibrator set containing a negative calibrator, a Level 1 calibrator at 500ng/mL, a Level 2 calibrator at 1000ng/mL, a Level 3 calibrator at 1500ng/mL, and a Level 4 calibrator at 2000ng/mL.
- E. Intended Use
The Immunalysis Amphetamine Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with dual cutoffs of 500ng/mL and 1000ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Amphetamine in human urine with automated clinical chemistry analyzers. This assay is calibrated against Amphetamine. This in-vitro device is for prescription use only.
The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures.
The Immunalysis Amphetamine 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 consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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Immunalysis Amphetamine Urine Controls: The Immunalysis Amphetamine Urine Controls are used as control materials in Imunalysis Amphetamine Urine Enzyme Immunoassay.
Immunalysis Amphetamine Urine Calibrators: The Immunalysis Amphetamine Urine Calibrators are used as calibrators in the Immunalysis Amphetamine Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Amphetamine in urine on automated clinical chemistry analyzers
| Item | Amphetamine Assay K062077 | Immunalysis Amphetamine Urine EIA |
|---|---|---|
| Intended Use | For the qualitative and semi- | |
| quantitative determination of the | ||
| presence of amphetamine in human | ||
| urine at a cutoff of 500ng/mL and | ||
| 1000ng/mL | For the qualitative and semi-quantitative | |
| determination of the presence of | ||
| amphetamine in human urine at a cutoff of | ||
| 500ng/mL and 1000ng/mL | ||
| Type of Product | Analytical Reagents | Analytical Reagents |
| Measured Analytes | Amphetamine | Amphetamine |
| Test Matrix | Urine | Urine |
| Cutoff Levels | 500ng/mL and 1000ng/mL of | |
| Amphetamine | 500ng/mL and 1000ng/mL of | |
| Amphetamine | ||
| Test System | Homogeneous Enzyme Immunoassay | Homogenous 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 | Mouse Monoclonal antibodies to | |
| Amphetamine and Methamphetamine | Monoclonal antibody to Amphetamine | |
| Storage | 2 – 8°C until expiration date | 2 – 8°C until expiration date |
| Calibrator Form | Liquid | Liquid |
| Calibrator Levels | Six (6) Levels | Two (2) Levels and Five (5) Levels |
| Control Levels | Five (5) Levels | Four (4) Levels |
-
F. Comparison of the new device with the predicate device
G. The following laboratory performance studies were performed to determine substantial equivalence of the Immunalysis Amphetamine Urine Enzyme Immunoassay to the predicate -
Precision/Cutoff Characterization Study was performed for 20 days, 2 runs per 1. day in duplicate (N=80) on concentration of ±25%, ±50%, ±75%, and ±100% of the cutoff. The study verified that the cutoff serves as a boundary between a negative and positive interpretation of a qualitative result. In addition, it also verified that product performance relative to the ability of the device to produce the same value during repeated measurements. The instruments used for this was Beckman Coulter AU 400e.
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| Table 1 - 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 | 48 Negative / 32 Positive |
| 625 | +25% | 80 | 80 Positive |
| 750 | +50% | 80 | 80 Positive |
| 875 | +75% | 80 | 80 Positive |
| 1000 | +100% | 80 | 80 Positive |
- a. The following is a summary table of the Qualitative Analysis for the 500ng/mL cutoff test data results.
- b. The following is a summary table of the Qualitative Analysis for the 1000ng/mL cutoff test data results
| Table 2 - 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 | 47 Negative / 33 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |
c. The following is a summary table of the Semi-Quantitative Analysis for the 500ng/mL cutoff test data results.
| Table 3 - 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 | 31 Negative / 49 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 - 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 | 36 Negative / 44 Positive |
| 1250 | +25% | 80 | 80 Positive |
| 1500 | +50% | 80 | 80 Positive |
| 1750 | +75% | 80 | 80 Positive |
| 2000 | +100% | 80 | 80 Positive |
- d. The following is a summary table of the Semi-Quantitative Analysis for the 1000ng/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 cutoffs. The study verified assay performance relative to the ability of the device to exclusively determine certain drugs. The instrument used for this test was a Beckman Coulter AU 400e.
- a. The qualitative result summary table for the 500ng/mL cutoff is outlined below:
| Table 5 - Structurally Related Compounds (for 500 ng/mL cutoff) - Qualitative | |||
|---|---|---|---|
| Compound | Concentration Tested (ng/mL) | Result | Cross-Reactivity (%) |
| (+) Amphetamine | 500 | POS | 100.0 |
| (-) Amphetamine | 100,000 | POS | 0.5 |
| (±) Amphetamine | 1,300 | POS | 38.5 |
| MDA | 1,500 | POS | 33.3 |
| PMA | 2,000 | POS | 25.0 |
| Tyramine | 100,000 | POS | 0.5 |
| MDMA | 500,000 | POS | 0.1 |
| MDEA | 100,000 | POS | 0.5 |
| Phenylpropanolamine | 500,000 | POS | 0.1 |
| Phentermine | 1,000,000 | POS | 0.05 |
| (+) Methamphetamine | 1,000,000 | POS | 0.05 |
| (-) Methamphetamine | 1,000,000 | NEG | N.D. |
| (+) Ephedrine | 1,000,000 | NEG | N.D. |
| (-) Ephedrine | 1,000,000 | NEG | N.D. |
| (+) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| (-) Pseudoephedrine | 1,000,000 | NEG | N.D. |
| Phenylephrine | 1,000,000 | NEG | N.D. |
| Diphenylhydramine | 1,000,000 | NEG | N.D. |
| Fenfluramine | 1,000,000 | NEG | N.D. |
N.D. = 750 ng/mL | |
| Qualitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/ Negative | 36 | 4 | 0 | 0 | 100 |
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- c. The following is a comparison table of qualitative assay performance for the 1,000ng/mL cutoff:
Table 22 - Method Comparison (for 1000ng/mL cutoff) - Qualitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 0 |
| (-) | 1 | 40 |
d. The following is a summary table of qualitative assay performance for the 1,000ng/mL
| Table 23 - Assay Performance verified by LC/MS – 1000ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Amphetamine Concentration | Agreement | |||
| (%) | |||||
| 1500 ng/mL | |||||
| Qualitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Qualitative/ Negative | 34 | 6 | 1 | 0 | 98 |
e. The following is a summary table of qualitative discordant results for the 1000ng/mL cutoff
| Table 24 - Discordant Result Summary – 1000ng/mL Cutoff – Qualitative | |||
|---|---|---|---|
| Sample ID | In-House ID | Qualitative Results 1000ng/mL Cutoff | |
| Test Device | LC/MS Confirmation | ||
| Amphetamine | |||
| 395246ZA | 16558 | Negative | 1173ng/mL |
f. The following is a comparison table of semi-quantitative assay performance for the 500ng/mL cutoff:
Table 25 - Method Comparison (for 500ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 0 |
| (-) | 0 | 40 |
g. The following is a summary table of semi-quantitative assay performance for the 500ng/mL cutoff:
| Table 26 - Assay Performance verified by LC/MS – 500ng/mL Cutoff | |||||
|---|---|---|---|---|---|
| Type | Amphetamine Concentration | Agreement | |||
| (%) | |||||
| 750 ng/mL | |||||
| Semi-Quantitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Semi-Quantitative / Negative | 36 | 4 | 0 | 0 | 100 |
h.The following is a comparison table of semi-quantitative assay performance for the 1,000ng/mL cutoff:
Table 27 - Method Comparison (for 1000ng/mL cutoff) - Semi-Quantitative
| LC/MS Confirmation | |||
|---|---|---|---|
| (+) | (-) | ||
| Test | |||
| Device | (+) | 40 | 0 |
| (-) | 1 | 40 |
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i. The following is a summary table of semi-quantitative assay performance for the 1,000ng/mL cutoff:
| Type | Amphetamine Concentration | | | | Agreement
(%) |
|------------------------------|---------------------------|-----------------|-------------------|--------------|------------------|
| | 1500 ng/mL | |
| Semi-Quantitative/ Positive | 0 | 0 | 4 | 36 | 100 |
| Semi-Quantitative / Negative | 34 | 6 | 1 | 0 | 98 |
j. The following is a summary table of semi-quantitative discordant results for the 1000ng/mL cutoff
| Table 29 - Discordant Result Summary – 1000ng/mL Cutoff – Semi-Quantitative | ||||
|---|---|---|---|---|
| Sample ID | In-House ID | Semi-Quantitative Results 1000ng/mL Cutoff | LC/MS Confirmation | |
| Value | Result | Amphetamine | ||
| 395246ZA | 16558 | 620.6 | Negative | 1173ng/mL |
- Stability -
- a. A closed accelerated stability study was performed on reagents, calibrators and controls at 25℃ to establish the initial expiration dating. The stability study supported an initial expiration date of 1 year for reagents. This stability study supported an initial expiration date of 12 months for calibrators and controls. The instrument used for this test was a Beckman Coulter AU 400e. Real time stability studies are ongoing.
- b.An open/on-board stability study was performed on reagents to establish expiration dating when reagents are opened and stored on board the instrument at 2℃ to 8℃. The stability study supported an initial open vial expiration date of 28 days. The instrument used for this test was Beckman Coulter AU 400e.
-
- Calibrator and Control Traceability all components of the calibrator and controls have been traced to a commercially available standard solution
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- Calibrator and Control Stability - An open accelerated stability study was performed at 25°C to establish the initial open vial expiration dating. The stability study supported an initial open vial expiration date of 6 months. The instrument used for this test was a Beckman Coulter AU 400e. All calibrator levels (500, 1,000, 1,500, and 2,000ng/mL) and control levels (375,625, 750, 1,250ng/mL) were within specifications for Day 0, 8, 16, 32, and 40. This accelerated stability study was performed to establish initial expiration dating. Real time stability studies are ongoing.
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- Calibrator and Control Value Assignment calibrators and controls are manufactured and are tested by mass spectrometry. If any of the analytes are out of the acceptable range, then the calibrator and control is adjusted and re-tested. Values are assigned to the calibrator and controls once the mass spectrometry results are within the acceptable ranges.
- H. Conclusion
The information provided in this pre-market notification demonstrates that the Immunalysis Amphetamine Urine Enzyme Immunoassay is substantially equivalent to the legally marketed predicate device for its general intended use.