(60 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.
Note: This document describes a traditional in-vitro diagnostic (IVD) device (immunoassay for drug detection) and not an AI/ML-driven medical device, hence many of the requested points related to AI/ML device validation (e.g., number of experts for ground truth, MRMC study, training set details) are not applicable. I will indicate "N/A" for these points.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the study success definitions and the comparison to the predicate device.
| Acceptance Criteria & Study Success Definition (Implied) | Reported Device Performance (Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers) |
|---|---|
| Precision: Demonstrate acceptable within-run and total precision across various Methamphetamine (MAMP) levels, with expected interpretation around the 500 ng/mL cutoff. | Total Precision (84 samples per level): - 0-375 ng/mL: 100% Negative- 500 ng/mL: 49% Negative (41 samples), 51% Positive (43 samples)- 625-1000 ng/mL: 100% PositiveWithin Run Precision (19-20 samples per level): - 0-375 ng/mL: 100% Negative- 500 ng/mL: 60% Negative (12 samples), 40% Positive (8 samples)- 625-1000 ng/mL: 100% Positive (one sample at 625 showed 19 samples, all positive) |
| Cross Reactivity: Demonstrate similar cross-reactivity profiles to the predicate device for structurally related compounds. | Pictus P700 vs. Hitachi 717 (Predicate): - d-Methamphetamine (500 ng/mL): Positive (P700) / 211 (Hitachi)- d-Amphetamine (50,000 ng/mL): Positive (P700) / 212.1 (Hitachi)- Methylenedioxyamphetamine (MDA) (72,500 ng/mL): Positive (P700) / 210.1 (Hitachi)- Methylenedioxymethylamphetamine (MDMA) (1,500 ng/mL): Positive (P700) / 207.8 (Hitachi)The results demonstrated "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 Comparison: | Pictus 700 Methamphetamine Tests vs LC/MS Reference (98 samples):- 0-350 ng/mL (negative samples by LC/MS): - LC/MS <50% of COV (Negative): 23 negative - LC/MS <70% of COV (Negative): 7 negative - All samples in this range (15 + 23 + 7 = 45) were reported as negative by Pictus 700 (98.0% agreement for negative samples, with one discordant sample at 488 ng/mL reported positive by Candidate).- 650 ng/mL or higher (positive samples by LC/MS): - LC/MS >30% of CO (Positive): 5 positive - LC/MS >50% of COV (Positive): 7 positive - LC/MS Very High Positive: 21 positive - All samples in this range (5 + 7 + 21 = 33) were reported as positive by Pictus 700 (100.0% agreement for positive samples).- Between 351 and 649 ng/mL (around cutoff): At least 95% congruent in terms of negative and positive results on either side of the 500 ng/mL cutoff. - LC/MS Near CO Negative (351-499 ng/mL): 4 negative, 1 positive (discordant sample 61634620, LC/MS 488, Candidate 514 positive) - LC/MS Near CO Positive (501-650 ng/mL): 15 positive, 0 negative - The overall accuracy was 98.0% for negative agreement and 100.0% for positive agreement against GC/MS. |
| On-board Reagent Stability: Reagent must be stable on the analyzer for at least 14 days, with a calibration frequency of 7 days. | The LZI Methamphetamine reagent was found to be "stable on-board the Pictus 700 analyzer for at least 14 days, and calibration frequency is defined at 7 days." The study maintained accuracy over the 14-day period. |
2. Sample sizes used for the test set and the data provenance
- Precision:
- Total Precision: 84 samples per MAMP level (9 levels tested). Total samples = 84 * 9 = 756 individual sample runs across different levels.
- Within Run Precision: 19-20 samples per MAMP level (9 levels tested). Total samples = approximately 180 individual sample runs.
- Cross Reactivity: 4 structurally related compounds tested in duplicate.
- Accuracy - Method Comparison: 98 human urine samples.
- On-board Reagent Stability: 3 fresh sample pools, analyzed on Day 1, 3, 6, 7, 10, 13, 14, and 17 in duplicate or triplicate.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective as they involved systematically preparing samples at specific concentrations and testing them, or collecting fresh samples for analysis. This is typical for IVD assay validation studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. For IVD devices like this, ground truth is established by analytical methods, not human expert consensus. The "ground truth" for the accuracy study was established by Gas or Liquid Chromatography-Mass Spectrometry (GC/MS or LC/MS), which are laboratory-based confirmatory methods.
4. Adjudication method for the test set
N/A. Ground truth was established by LC/MS, an objective analytical method, so no human adjudication was required.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is not an AI-driven device. It is an automated laboratory assay.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The device (Pictus 700 with LZI MAMP reagent) performs the analysis automatically in a "standalone" fashion. The results are then interpreted as positive or negative based on the 500 ng/mL cutoff, which is essentially an "algorithm." There is no human interaction for result generation once samples are loaded. The study directly evaluates this standalone performance against the LC/MS reference method.
7. The type of ground truth used
The ground truth used was analytical measurement by Gas or Liquid Chromatography-Mass Spectrometry (GC/MS or LC/MS). For the purpose of drug testing, these are considered the gold standard confirmatory methods.
8. The sample size for the training set
N/A. This document pertains to an IVD reagent and instrument system, not an AI/ML model that requires a "training set" in the machine learning sense. The device is based on enzyme immunoassay chemistry.
9. How the ground truth for the training set was established
N/A. See point 8. The "training" for such a system involves calibrating the instrument with known calibrators, not training an algorithm on a large dataset.
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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
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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
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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)
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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 A113Medley, 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
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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 SystemLin-Zhi International,Inc. (LZI)MethamphetamineEnzyme Immunoassayfor Pictus Analyzers | Predicate SystemLZI MethamphetamineImmunoassay (K113661) |
|---|---|---|
| Instrument Platform | Pictus Analyzers | "Cleared for chemistry analyzers"(open system) |
| Mode of Detection/Photometric Detector | Photometric/Photodiode | Same |
| Wavelength to measureMethamphetamine reagent reactions | 340nm | Same |
| Characteristic | Candidate SystemLin-Zhi International, Inc. (LZI)MethamphetamineEnzyme Immunoassayfor Pictus Analyzers | Predicate SystemLZI MethamphetamineImmunoassay (K113661) |
| Intended Use & Sample type | The Lin-Zhi International, Inc.(LZI) Methamphetamine Enzyme Immunoassay for PictusAnalyzers is intended for thequalitative determination of d-methamphetamine in human urineat a cutoff value of 500 ng/mL.The system was calibrated with d-methamphetamine. The assayprovides a rapid screeningprocedure for determining thepresence of d-methamphetaminein urine.The assay provides only apreliminary analytical result. Amore specific alternativeanalytical chemistry method mustbe used in order to obtain aconfirmed analytical result. Gasor Liquid Chromatography/MassSpectrometry (GC/MS or LC/MS)are the preferred confirmatorymethods. Clinical considerationand professional judgment shouldbe exercised with any drug ofabuse test result, particularlywhen the preliminary test result ispositive. | The LZI Methamphetamine EnzymeImmunoassay is intended for thequalitative and semi-quantitativedetermination of d-methamphetamine in human urine,at the cutoff value of 500 ng/mL.The assay is designed forprofessional use with a number ofautomated chemistry analyzers.The semi-quantitative mode is forpurposes of (1) enablinglaboratories to determine anappropriate dilution of specimen forconfirmation by a confirmatorymethod such as GCMS or LCMS or(2) permitting laboratories toestablish quality control procedures.The LZI Methamphetamine Drugsof Abuse (DAU) Calibrators are foruse as calibrators in the qualitativeand semi-quantitative calibration ofthe LZI Methamphetamine EnzymeImmunoassay at a cutoff value of500 ng/mL.The LZI Methamphetamine Drugsof Abuse (DAU) Controls are foruse as assayed quality controlmaterials to monitor the precision ofthe LZI Methamphetamine EnzymeImmunoassay at a cutoff value of500 ng/mL.The assay provides only apreliminary analytical result. Amore specific alternative chemicalmethod must be used in order toobtain a confirmed analytical result.Gas or liquid chromatography/massspectrometry (GC/MS or LC/MS) isthe preferred confirmatory method.Clinical consideration andprofessional judgment should beexercised with any drug of abusetest result, particularly when thepreliminary test result is positive. |
| Characteristic | Candidate SystemDiatron Pictus 700 Analyzerwith LZI MethamphetamineEIA | Predicate SystemHitachi 717 Analyzer with LZIMethamphetamine 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 |
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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
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| Compound | TargetConcentration(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 | TargetConcentration(ng/mL) | P700QualitativeResult |
| 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 | TargetConcentration(ng/mL) | Hitachi 717QualitativeResult |
| 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
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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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| ZeroNegative | LC/MS <50%of COVNegativeng/mL (<251ng/mL) | LC/MS <70%of COVNegative(251-350ng/mL) | LC/MSNear CONegative(351-499ng/mL) | LC/MSNear COPositive(501-650ng/mL) | LC/MS>30% of COPositive(651-750ng/mL) | LC/MS>50% ofCOVPositive(751-1000ng/mL) | LC/MSVery HighPositive(>1000ng/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 | CandidatePositive (514) | LC/MS488 |
| Cut-Off Value (COV) | 500 ng/mL | Hitachi 717 Methamphetamine Tests vs LC/MS Reference | ||||
|---|---|---|---|---|---|---|
| Zero Negative | 1 to 250 ng< 50% ofthe COVNegative | 250 ng to500 ng <COVNegative | 500 ng to750 ng >COVpositive | HighPositive>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.
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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.
§ 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).