(60 days)
Not Found
No
The description details a standard enzyme immunoassay read by a clinical chemistry analyzer. There is no mention of AI/ML in the device description, intended use, or performance studies. The calculation of change in absorbance is a standard function of the analyzer, not indicative of AI/ML.
No
This device is for qualitative determination of d-methamphetamine in human urine for screening purposes and does not provide therapy.
Yes
The device is intended for the qualitative determination of d-methamphetamine in human urine, providing a rapid screening procedure for the presence of the substance. This falls under the definition of a diagnostic device as it aids in identifying a condition (presence of d-methamphetamine).
No
The device is an enzyme immunoassay reagent intended for use with automated clinical chemistry analyzers (hardware). While it utilizes software within the analyzer for calculations, the core of the device is a chemical reagent, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative determination of d-methamphetamine in human urine". This involves testing a sample taken from the human body (in vitro) to provide diagnostic information (determining the presence of a substance).
- Device Description: The description reinforces that it's for "qualitative determination of methamphetamine in human urine" and is designed for "laboratory use by trained professionals with various automated clinical chemistry analyzers." This aligns with the typical use case of IVD devices in a laboratory setting.
- Anatomical Site: The sample is "human urine," which is a biological specimen taken from the body.
- Performance Studies: The document details performance studies like Precision, Cross Reactivity, and Accuracy - Method Comparisons using human urine samples. This type of testing and validation is standard for IVD devices to demonstrate their analytical performance.
- Key Metrics: The reporting of metrics like % Agreement (Positive) and % Agreement (Negative) are common performance indicators for IVD tests.
- Predicate Device: The mention of a predicate device (K113661; LZI Methamphetamine Immunoassay reagent) is a strong indicator that this device is being submitted for regulatory clearance as an IVD, as predicate devices are used for comparison in the regulatory process for IVDs.
All these factors point to the device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of d-methamphetamine in urine.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Product codes
LAF
Device Description
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of methamphetamine in human urine, at a cutoff value of 500 ng/mL.
The assay is designed for laboratory use by trained professionals with various automated clinical chemistry analyzers.
This assay provides a rapid screening procedure for assessing the presence of d-methamphetamine in urine. The assay provides only a preliminary analytical result reported as a positive or negative. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. The analyzer photometer reads the absorbance at 340mm at time intervals dictated by the Methamphetamine application stored in the analyzer memory, and the change in absorbance is calculated automatically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
laboratory use by trained professionals
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
Precision:
Study Type: Precision (within-run and total)
Sample Size: 84 samples for total precision, 19-20 samples for within-run precision depending on the level.
Key Results:
- Total Precision: Samples at 0, 125, 250, 375 ng/mL were 100% negative. Samples at 625, 750, 875, 1000 ng/mL were 100% positive. At the 500 ng/mL cutoff, 49% were negative and 51% were positive.
- Within Run Precision: Samples at 0, 125, 250, 375 ng/mL were 100% negative. Samples at 625, 750, 875, 1000 ng/mL were 100% positive. At the 500 ng/mL cutoff, 60% were negative and 40% were positive.
Cross Reactivity:
Study Type: Cross Reactivity
Key Results: Four structurally related compounds (d-Methamphetamine M-020, d-Amphetamine A-008, Methylenedioxyamphetamine (MDA) M-012, Methylenedioxymethylamphetamine (MDMA) M-013) were tested. The results demonstrated that cross-reactivity of the reagents with the Pictus 700 was the same as that demonstrated with the same reagents on the Hitachi 717 (predicate system).
Accuracy - Method Comparisons:
Study Type: Accuracy (Method Comparison)
Sample Size: 98 human urine samples
Data Source: LC/MS assigned MAMP values
Key Results:
- Pictus 700 Methamphetamine Tests vs LC/MS Reference:
- Samples with LC/MS results = 650 ng/mL (LC/MS >30% of CO Positive, LC/MS >50% of COV Positive, LC/MS Very High Positive) were 100% positive (33/33).
- Samples with LC/MS results between 351 and 649 ng/mL (LC/MS Near CO Negative, LC/MS Near CO Positive) showed 1 discordant sample out of 20 (4 negative, 16 positive for P700). Overall agreement for positive results was 100.0% (48 positive samples), and for negative results was 98.0% (50 negative samples). One discordant sample (LC/MS 488 ng/mL) was positive (514) on the candidate system.
- Comparison to Predicate (Hitachi 717):
- Positive agreement for Hitachi 717: 97.9% (47 samples).
- Negative agreement for Hitachi 717: 100.0% (48 samples). One discordant result for Hitachi 717 (LC/MS 654 ng/mL) was negative.
On-board Methamphetamine Reagent Stability:
Study Type: On-board Reagent Stability
Key Results: The LZI Methamphetamine reagent is stable on-board the Pictus 700 analyzer for at least 14 days, with calibration frequency defined at 7 days.
Key Metrics
- Total Precision:
- @ 500 ng/mL: % Negative = 49%, % Positive = 51%
- Within Run Precision:
- @ 500 ng/mL: % Negative = 60%, % Positive = 40%
- Accuracy - Method Comparisons (Pictus 700):
- % Agreement for Positive (48 samples): 100.0%
- % Agreement for Negative (50 samples): 98.0%
- Accuracy - Method Comparisons (Hitachi 717 - Reference):
- % Agreement for Positive (47 samples): 97.9%
- % Agreement for Negative (48 samples): 100.0%
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 31, 2020
Diatron Group % Erika Ammirati President Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022
Re: K201442
Trade/Device Name: Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine Test System Regulatory Class: Class II Product Code: LAF Dated: May 29, 2020 Received: June 1, 2020
Dear Erika Ammirati:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201442
Device Name
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Indications for Use (Describe)
The Lin-Zhi International, Inc. (LZ) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of dmethamphetamine in urine.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid ChromatographyMass Spectrometry (GCMS or LC/ MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
July 31, 2020
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K201442.
| 807.92 (a)(1): Name: | Diatron, US, Inc. | |
|---|---|---|
| Address: | 12601 N.W. 115 Avenue, Suite A113 | |
| Medley, FL 34178 | ||
| Phone: | 833-228-7931 | |
| FAX: | 786-264-9460 | |
| Contact: | Mr. Frank Matusazak |
807.92 (a)(2): Device name- trade name and common name, and classification
Trade Name : Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers
Common Name: Homogeneous Enzyme Immunoassay for Drug of Abuse Methamphetamine Enzyme Immunoassay.
Classification Name (s):
21 CFR § 862.3610 - Methamphetamine test system Product Code: LAF Class II Panel: Toxicology 91
807.92 (a)(3): Identification of the legally marketed predicate de vices
LZI Methamphetamine Immunoassay reagent cleared under K113661
807.92 (a)(4): Device Description
Me thamphe tamine
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of methamphetamine in human urine, at a cutoff value of 500 ng/mL.
The assay is designed for laboratory use by trained professionals with various automated clinical chemistry analyzers.
This assay provides a rapid screening procedure for assessing the presence of dmethamphetamine in urine. The assay provides only a preliminary analytical result reported as a positive or negative. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive. The analyzer photometer reads the absorbance at 340mm at
4
time intervals dictated by the Methamphetamine application stored in the analyzer memory, and the change in absorbance is calculated automatically.
807.92 (a)(5): Intended Use
The Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers is intended for the qualitative determination of d-methamphetamine in human urine at a cutoff value of 500 ng/mL. The system was calibrated with d-methamphetamine. The assay provides a rapid screening procedure for determining the presence of d-methamphetamine in urine.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
The following chart describes similarities and differences between the two test systems.
| Characteristic | Candidate System
Lin-Zhi International,
Inc. (LZI)
Methamphetamine
Enzyme Immunoassay
for Pictus Analyzers | Predicate System
LZI Methamphetamine
Immunoassay (K113661) |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Instrument Platform | Pictus Analyzers | "Cleared for chemistry analyzers"
(open system) |
| Mode of Detection/Photometric Detector | Photometric/Photodiode | Same |
| Wavelength to measure
Methamphetamine reagent reactions | 340nm | Same |
| Characteristic | Candidate System
Lin-Zhi International, Inc. (LZI)
Methamphetamine
Enzyme Immunoassay
for Pictus Analyzers | Predicate System
LZI Methamphetamine
Immunoassay (K113661) |
| Intended Use & Sample type | The Lin-Zhi International, Inc.
(LZI) Methamphetamine Enzyme Immunoassay for Pictus
Analyzers is intended for the
qualitative determination of d-
methamphetamine in human urine
at a cutoff value of 500 ng/mL.
The system was calibrated with d-
methamphetamine. The assay
provides a rapid screening
procedure for determining the
presence of d-methamphetamine
in urine.
The assay provides only a
preliminary analytical result. A
more specific alternative
analytical chemistry method must
be used in order to obtain a
confirmed analytical result. Gas
or Liquid Chromatography/Mass
Spectrometry (GC/MS or LC/MS)
are the preferred confirmatory
methods. Clinical consideration
and professional judgment should
be exercised with any drug of
abuse test result, particularly
when the preliminary test result is
positive. | The LZI Methamphetamine Enzyme
Immunoassay is intended for the
qualitative and semi-quantitative
determination of d-
methamphetamine in human urine,
at the cutoff value of 500 ng/mL.
The assay is designed for
professional use with a number of
automated chemistry analyzers.
The semi-quantitative mode is for
purposes of (1) enabling
laboratories to determine an
appropriate dilution of specimen for
confirmation by a confirmatory
method such as GCMS or LCMS or
(2) permitting laboratories to
establish quality control procedures.
The LZI Methamphetamine Drugs
of Abuse (DAU) Calibrators are for
use as calibrators in the qualitative
and semi-quantitative calibration of
the LZI Methamphetamine Enzyme
Immunoassay at a cutoff value of
500 ng/mL.
The LZI Methamphetamine Drugs
of Abuse (DAU) Controls are for
use as assayed quality control
materials to monitor the precision of
the LZI Methamphetamine Enzyme
Immunoassay at a cutoff value of
500 ng/mL.
The assay provides only a
preliminary analytical result. A
more specific alternative chemical
method must be used in order to
obtain a confirmed analytical result.
Gas or liquid chromatography/mass
spectrometry (GC/MS or LC/MS) is
the preferred confirmatory method.
Clinical consideration and
professional judgment should be
exercised with any drug of abuse
test result, particularly when the
preliminary test result is positive. |
| Characteristic | Candidate System
Diatron Pictus 700 Analyzer
with LZI Methamphetamine
EIA | Predicate System
Hitachi 717 Analyzer with LZI
Methamphetamine EIA
(K113661) |
| Cut-off : Negative/Positive level | 500 ng/mL | Same |
| Device Class , Regulation Code | Class II, 21 CFR § 862.3610 -
Methamphetamine reagent, LAF | Same |
5
6
807.92 (b)(1): Brief Description of Nonclinical Data
Precision:
Studies for within-run and total precision were performed at nine MAMP levels following CLSI EP05-A2. From these results, means, standard deviations, and percent coefficients of variation were calculated, and summarized data are shown below. In addition to the absorbance outputs, the data were assessed for "positive" and "negative" interpretation at either side of the 500 ng/mL cutpoint.
| Total Precision | |||||
|---|---|---|---|---|---|
| Level | Samples | % Negative | # Neg | % Positive | # Pos |
| 0 | 84 | 100% | 84 | 0% | 0 |
| 125 | 84 | 100% | 84 | 0% | 0 |
| 250 | 84 | 100% | 84 | 0% | 0 |
| 375 | 84 | 100% | 84 | 0% | 0 |
| 500 | 84 | 49% | 41 | 51% | 43 |
| 625 | 84 | 0% | 0 | 100% | 84 |
| 750 | 84 | 0% | 0 | 100% | 84 |
| 875 | 84 | 0% | 0 | 100% | 84 |
| 1000 | 84 | 0% | 0 | 100% | 84 |
Within Run Precision
| Level | Samples | % Negative | # Neg | % Positive | # Pos |
|---|---|---|---|---|---|
| 0 | 20 | 100% | 20 | 0% | 0 |
| 125 | 20 | 100% | 20 | 0% | 0 |
| 250 | 20 | 100% | 20 | 0% | 0 |
| 375 | 20 | 100% | 20 | 0% | 0 |
| 500 | 20 | 60% | 12 | 40% | 8 |
| 625 | 19 | 0% | 0 | 100% | 19 |
| 750 | 20 | 0% | 0 | 100% | 20 |
| 875 | 20 | 0% | 0 | 100% | 20 |
| 1000 | 20 | 0% | 0 | 100% | 20 |
Cross Reactivity
Four structurally related compounds were tested in duplicate at the concentrations described below. Other structurally and non-structurally related compounds were not tested as this system
7
| Compound | Target
Concentration
(ng/mL) |
|----------------------------------------------|------------------------------------|
| d-Mathamhetamine M-020 | 500 |
| d-Amphetamine A-008 | 50,000 |
| Methylenedioxyamphetamine (MDA) M-012 | 72,500 |
| Methylenedioxymethylamphetamine (MDMA) M-013 | 1,500 |
utilizes reagents that have already been assayed and described.
The results are shown below, followed by the results as generated on the Hitachi 717 (predicate system).
| Pictus P700 | ||
|---|---|---|
| Compound | Target | |
| Concentration | ||
| (ng/mL) | P700 | |
| Qualitative | ||
| Result | ||
| d-Methamhetamine M-020 | 500 | Positive |
| d-Amphetamine A-008 | 50,000 | Positive |
| Methylenedioxyamphetamine (MDA) M-012 | 72,500 | Positive |
| Methylenedioxymethylamphetamine (MDMA) M-013 | 1,500 | Positive |
| Reference | ||
|---|---|---|
| Compound | Target | |
| Concentration | ||
| (ng/mL) | Hitachi 717 | |
| Qualitative | ||
| Result | ||
| d-Mathamhetamine M-020 | 500 | 211 |
| d-Amphetamine A-008 | 50,000 | 212.1 |
| Methylenedioxyamphetamine (MDA) M-012 | 72,500 | 210.1 |
| Methylenedioxymethylamphetamine (MDMA) M-013 | 1,500 | 207.8 |
The results demonstrate that cross-reactivity of the reagents with the Pictus 700 was the same as that demonstrated with the same reagents on the Hitachi 717.
Accuracy - Method Comnarisons:
Ninety-eight (98) human urine samples with a span MAMP values between zero and 2,000 ng/mL (as value assigned by LC/MS) were assayed with the Pictus 700 system. As the Pictus 700 system reports qualitative results with a cutoff at 500 ng/mL, study success was defined as follows:
-
- LC/MS results reported as 350 ng/mL or lower must be negative.
- LC/MS results reported as 650 ng/mL or higher must be reported as positive. 2)
-
- LC/MS results reported between 351 and 649 ng/mL must be at least 95% congruent in terms of negative and positive results on either side of the 500 ng/mL cutoff.
-
- Pictus 700 results should determine negative and positive results in a similar fashion
8
to the LZI MAMP reagent submission data used to obtain clearance (K113661). Results are shown below.
| Cut-Off Value 500 ng/mL | Pictus 700 Methamphetamine Tests vs LC/MS Reference | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Zero | |||||||||
| Negative | LC/MS 30% of CO | ||||||||
| Positive | |||||||||
| (651- | |||||||||
| 750ng/mL) | LC/MS |
50% of
COV
Positive
(751-
1000ng/mL) | LC/MS
Very High
Positive
(>1000
ng/mL) | % Agree |
| Positive (48 samples) | 0 | 0 | 0 | 1 | 15 | 5 | 7 | 21 | 100.0% |
| Negative (50 samples) | 15 | 23 | 7 | 4 | 0 | 0 | 0 | 0 | 98.0% |
| Discordant Sample 61634620 | | Candidate
Positive (514) | LC/MS
488 | | | | | | |
| Cut-Off Value (COV) | 500 ng/mL | Hitachi 717 Methamphetamine Tests vs LC/MS Reference | ||||
|---|---|---|---|---|---|---|
| Zero Negative | 1 to 250 ng |
COV
positive | High
Positive
750ng | %
Agreement |
| Positive (47 samples) | 0 | 0 | 0 | 9 | 37 | 97.9% |
| Negative (48 samples) | 20 | 16 | 12 | 1 | 0 | 100.0% |
Discordant result LC/MS Result 654 ng/mL Test result Hitachi 717 Negative
On-board Methamphetamine Reagent Stability
The MAMP reagent has been previously cleared, and there have been no material changes to the components or manufacturing process since its clearance. An on-board reagent stability study was undertaken to validate open vial stability for the LZI MAMP reagent on the Pictus 700 for a two-week period.
Sufficient quantity of LZI MAMP reagent was added to a Pictus 700 reagent cartridge and loaded onto the Pictus 700 analyzer's cooled reagent tray. Three fresh sample pools with known methamphetamine concentrations were analyzed on Day 1, 3, 6, 7, 10, 13, 14 and 17 in duplicate or triplicate, and mean results for each day are compared to the Day 1 levels.
The LZI Methamphetamine reagent is stable on-board the Pictus 700 analyzer for at least 14 days, and calibration frequency is defined at 7 days.
9
807.92 (b)(2): Brief Description of Clinical Data
Not applicable
807.92 (b)(3): Conclusions from Nonclinical and Clinical Testing
The Diatron Pictus 700 Chemistry Analyzer using LZI-MAMP reagent for the qualitative determination of MAMP in human urine is substantially equivalent to the LZI-MAMP reagent when used on the Hitachi 717, cleared under K113661. The system is an effective screening system for validated drugs of abuse screening.