(412 days)
Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).
Amphetamines II 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) is the preferred confirmatory method. Clinical consideration and professional iudgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Amphetamines II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug-polymer conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the conjugate-bound drug derivative for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited.
The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
The provided text describes the 510(k) summary for the Amphetamines II Assay, Hitachi 917. However, it does not contain the specific details required to answer all parts of your request, particularly regarding detailed study results, acceptance criteria tables with performance, sample sizes for test sets with data provenance, number and qualifications of experts, adjudication methods, MRMC studies, or training set information.
The document primarily focuses on describing the device, its intended use, and its substantial equivalence to predicate devices, as required for 510(k) clearance. Clinical performance data, when present in such documents, often provides high-level summaries rather than granular details.
Here's a breakdown of what information can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as a table with numerical targets. The document focuses on demonstrating "substantial equivalence" to predicate devices and adherence to the intended use. The various cutoff concentrations (300, 500, 1000 ng/mL) could be considered implicit 'targets' for detection.
- Reported Device Performance: No quantitative performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are presented in a formal table with acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Not provided. The document describes the assay but does not detail the clinical study design, including the number of samples used for testing, their origin, or whether they were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable/Not provided. For a drug assay like this, the "ground truth" is typically established by a reference method (e.g., GC/MS), not by human experts interpreting results. The document states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
4. Adjudication Method for the Test Set:
- Not applicable/Not provided. As stated above, ground truth for this type of device is chemical confirmation, not human adjudication.
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:
- Not applicable. This device is a diagnostic assay (chemical kit) and does not involve human readers interpreting images or data alongside an AI. Therefore, an MRMC study and AI assistance improvement are not relevant concepts for this product.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device itself is a standalone analytical test system. Its performance is evaluated on its ability to detect amphetamines and methamphetamines in urine samples. The purpose of the assay is to provide a "preliminary analytical test result," which then requires a confirmatory method like GC/MS. This means the device itself operates without human interpretation of its internal mechanics, but its results are then interpreted by laboratory personnel. However, there are no specific standalone performance metrics (like sensitivity/specificity) for the device itself against a ground truth mentioned in the provided text.
7. The Type of Ground Truth Used:
- Confirmatory chemical method, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
8. The Sample Size for the Training Set:
- Not provided. This information is typically not included in a 510(k) summary for this type of device, as "training sets" are more commonly associated with machine learning algorithms. For chemical assays, the development process involves reagent optimization and validation, rather than a distinct "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
In summary, while the provided 510(k) summary clearly describes the device and its intended use, it lacks the detailed study performance data, sample sizes, and expert ground truth information that would be typical for an AI/software device submission. This is expected, as the Amphetamines II Assay is a chemical diagnostic kit, and its regulatory submission focuses on different aspects of validation compared to, for instance, an AI-powered image analysis system.
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510(k) Summary: Amphetamines II Assay, Hitachi 917
·
| Introduction | According to the requirements of 21 CFR 807.92, the followinginformation provides sufficient detail to understand the basis for adetermination of substantial equivalence. | |
|---|---|---|
| SubmitterName, Address,Contact | Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250317-521-3742 | FEB - 3 201 |
| Contact Person: Michelle Neff | ||
| Device Name | Proprietary name: Amphetamines II | |
| Common name: Amphetamine metabolite test system | ||
| Classification name:Enzyme Immunoassay, AmphetamineGas Chromatography, Methamphetamine | ||
| Product Code: DKZ, LAF | ||
| DeviceDescription | The Amphetamines II assay is based on the kinetic interaction ofmicroparticles in a solution (KIMS) as measured by changes in lighttransmission. In the absence of sample drug, soluble drug-polymerconjugates bind to antibody-bound microparticles, causing theformation of particle aggregates. As the aggregation reactionproceeds in the absence of sample, the absorbance increases. | |
| When a urine sample contains the drug in question, this drug competeswith the conjugate-bound drug derivative for microparticle-boundantibody. Antibody bound to sample drug is no longer available topromote particle aggregation, and subsequent particle lattice formationis inhibited. | ||
| The presence of sample drug diminishes the increasing absorbance inproportion to the concentration of drug in the sample. Sample drugcontent is determined relative to the value obtained for a known cutoffconcentration of drug. |
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510(k) Summary: Amphetamines II Assay, Hitachi 917
Intended Use
Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).
Amphetamines II 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) is the preferred confirmatory method.1 Clinical consideration and professional iudgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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510(k) Summary: Amphetamines II Assay, Hitachi 917
Comparison to the Predicate Device
The ONLINE Amphetamines II assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed Abuscreen ONLINE Amphetamines assay (K983699).
The ONLINE Amphetamines II assay contains an in vitro diagnostic reagent system intended for use on the Roche/Hitachi 917 analyzer for the semi-quantitative and qualitative detection of amphetamines in human urine at cutoff concentrations of 300, 500, and 1000 ng/mL.
The Roche ONLINE Amphetamines II assay utilizes a modified KIMS technology relative to the currently marketed Abuscreen OnLine Amphetamines assay. Differences between this application and the cleared assay include:
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- use of amphetamine and methamphetamine, and monoclonal antibodies attached to microparticles in solution
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- a soluble drug-polymer conjugate
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- increased sensitivity to "designer drugs" and their metabolites, and
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- addition of 300 and 500 ng/mL cutoff concentrations.
The recommended calibrators to be used with the proposed ONLINE Amphetamines II assay are the Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators (K060645).
The recommended controls to be used with the proposed ONLINE Amphetamines II assay are the Control Set DAT I, Control Set DAT II, Control Set DAT III (K080183).
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510 Summary: Amphetamines II Assay, Hitachi 917
| Feature | Roche Amphetamines II Assay | Predicate Device: ONLINE Amphetamines(K983699) |
|---|---|---|
| Methodology | Same | KIMS, Kinetic interaction of microparticles insolution |
| Sample Type | Same | Urine |
| Intended Use | Qualitative and semi-quantitative detection ofamphetamine and methamphetamine | Qualitative and semi-quantitative detection ofamphetamine and methamphetamine and theirmetabolites |
| Cutoff | 300, 500, 1000 ng/mL | 1000 ng/mL |
| Calibrator/Control Matrix | Same | Human urine |
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510 Summary: Amphetamines II Assay, Hitachi 917
| Feature | Roche Amphetamines II Assay | Predicate Device: AbbottAmphetamine/Methamphetamine (K012998) |
|---|---|---|
| Methodology | KIMS, Kinetic interaction of microparticles in solution | Homogenous enzyme immunoassay |
| Sample Type | Same | Urine |
| Intended Use | Qualitative and semi-quantitative detection of amphetamine and methamphetamine | Qualitative detection of amphetamine/methamphetamine |
| Cutoff | 300, 500, 1000 ng/mL | 1000 ng/mL |
| Calibrator/Control Matrix | Same | Human urine |
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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Roche Diagnostics Corporation c/o Ms. Michelle Neff Regulatory Principal 9115 Hague Road Indianapolis, IN 46250
FEB - 3 2010
Re: K083764
Trade Name: ONLINE DAT II Amphetamines II Regulation Number: 21 CFR §862.3100 Regulation Name: Enzyme Immunoassay, Amphetamine Regulatory Class: Class II Product Codes: DKZ, LAF Dated: December 02, 2009 Received: December 03, 2009
Dear Ms. Neff:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
CA
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name: ONLINE DAT II Amphetamines II
Indication For Use:
Amphetamines II (AMPII) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamines and methamphetamines on automated clinical chemistry analyzers at cutoff concentrations of 300 ng/mL, 500 ng/mL and 1000 ng/mL when calibrated with d-methamphetamine. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC/MS).
Amphetamines II 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) is the preferred confirmatory method.4 Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol (Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083764
§ 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).