(76 days)
DAT Oral Fluid Amphetamine (OFAMP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.
DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Oral Fluid DAT Control Set B is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
The Oral Fluid DAT Qual Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept® Oral Specimen Collection Device.
The Oral Fluid DAT SQ Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate 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.
Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically in a synthetic oral fluid matrix at the following concentrations: 0, 20, 40, 80, 160, and 320 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS.
The provided text describes the "DAT Oral Fluid Amphetamine Assay" for the qualitative and semiquantitative detection of amphetamine in human oral fluid. It focuses on the device's intended use and substantial equivalence to a predicate device, but does not contain the specific details about acceptance criteria, a study that proves the device meets those criteria, or information about sample sizes, ground truth establishment, or expert involvement as requested in your prompt.
Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract what information is available and indicate where information is missing.
Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" through a table or specific percentage/thresholds for performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself. It only defines the cutoff concentration and the intended use.
1. Table of acceptance criteria and the reported device performance
Since explicit acceptance criteria are not provided in the document, I cannot create a table directly. The key performance aspect mentioned is the detection cutoff, which is fundamental to the assay's function.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. | Device is designed for and intended to perform qualitative and semiquantitative detection of amphetamine at a cutoff concentration of 120 ng/mL in neat oral fluid. This is its stated capability, but specific validation results demonstrating performance against a defined criterion (e.g., >95% accuracy at cutoff) are not present. |
Missing Information: The document does not provide a study with specific results (e.g., sensitivity, specificity, accuracy, precision data) that would demonstrate the device meets performance acceptance criteria. It focuses on the device's design and intended use for substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing Information: The document does not mention any sample sizes for test sets, data provenance (country of origin), or whether any studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Missing Information: The document does not describe any test set, experts, or their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing Information: No test set or adjudication method is mentioned.
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 an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results in an MRMC study. The "AI" component is irrelevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is an in vitro diagnostic assay. Its performance is inherent to its chemical/biological reaction and instrumental measurement. As such, it operates "standalone" in the sense that once the oral fluid is introduced to the assay, the chemical reaction and measurement yield a result without constant human intervention in the result generation process itself, though human interpretation of that result is required.
However, the document does not describe a specific "standalone performance study" with detailed metrics. It states: "DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method." This indicates that the device is intended to operate as a standalone screening tool, but its results are preliminary and require confirmation by a "gold standard" method.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states: "Chromatography/mass spectrometry is the preferred confirmatory method." This implies that LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) serves as the "ground truth" or "gold standard" confirmatory method for drug presence and concentration.
The calibrators and controls used for the assay are also "verified by LC/MS/MS" which means LC/MS/MS is used to establish the true concentrations for these reference materials.
8. The sample size for the training set
Missing Information: The document does not mention any training sets or their sample sizes. This type of information is typically relevant for machine learning or AI-based devices, which this assay is not.
9. How the ground truth for the training set was established
Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not provided.
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510(k) Summary: Oral Fluid Amphetamine Assay
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. MAY - 3 2011 |
|---|---|
| Submitter Name, Address, Contact | Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250317-521-3742Contact Person: Michelle NeffDate Prepared: April 11, 2011 |
| Device Name | Proprietary name: Oral Fluid Amphetamine AssayCommon name: Amphetamine test systemClassification name: Enzyme Immunoassay, AmphetamineProduct Code: DKZ |
| Device Description | The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate 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.Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically in a synthetic oral fluid matrix at the following concentrations: 0, 20, 40, 80, 160, and 320 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS. |
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DAT Oral Fluid Amphetamine (OFAMP) is an in vitro diagnostic test for the Intended Use qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.
DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Oral Fluid DAT Control Set B is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
· The Oral Fluid DAT Qual Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept® Oral Specimen Collection Device.
The Oral Fluid DAT SQ Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept® Oral Specimen Collection Device,
Comparison to Predicate Device
The Oral Fluid Amphetamine assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, we claim substantial equivalence to the currently marketed Amphetamine-Specific Intercept® Micro-Plate EIA assay (K992918).
| Feature | Roche Oral Fluid Amphetamine Assay | Predicate Device: Amphetamine-Specific Intercept® MICRO-PLATE EIA (K992918) |
|---|---|---|
| Methodology | KIMS, Kinetic interaction of microparticles insolution | Competitive micro-plate immunoassay |
| Sample Type | Oral Fluid | Oral Fluid |
| Intended Use | Qualitative and semi-quantitative detection ofAmphetamine | Qualitative detection ofAmphetamines |
| Neat Cutoff | 120 ng/mL in Neat Oral Fluid | 100 ng/mL when oral fluid collectedwith the Oral Specimen CollectionDevice |
| Controls | Synthetic oral fluid matrix:Zero, Negative (.5X), and Positive (1.5X) | Synthetic oral fluid matrix:Negative (.5X) and Positive (2X) |
| Calibrator | Synthetic oral fluid matrix:Zero, .5X, Cutoff, 2X, 4X, and 8X | Synthetic oral fluid matrix:Zero, Cutoff |
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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or other bird with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
3 2011 HAY
Roche Diagnostics c/o Ms. Michelle Lee Neff Regulatory Affairs Principal 9115 Hague Road, PO Box 50416 Indianapolis, IN, 46250-0416
Re: K110446
Trade Name: DAT Oral Fluid Amphetamine Assay, Oral Fluid DAT Qual Cal B. Oral Fluid DAT SQ Cal B and Oral Fluid DAT Control Set B Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: DKZ, DKB, DIF Dated: February 15, 2011 Received: February 16, 2011
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
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Page 2 -
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 C.F.R.)
5450 - Also, places not other of In Vitro Diagnostic Device Evaluation and Safety at (301 5450. 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 Small Manufacturers, International and Consumer Assistance at its toll the Act Trim the
(800) 638-2041 or (201) 706-7140 - entity In 1 consumer Assistance at its (800) 638-2041 or (301) 796-7100 or at its Internet and Consume http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courthey 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
KII 0446 510(k) Number (if known):
Device Name: Oral Fluid Amphetamine Indication For Use:
DAT Oral Fluid Amphetamine (OFAMP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/ml in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.
DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Oral Fluid DAT Control Set B is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept" Oral Specimen Collection Device.
The Oral Fluid DAT Qual Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept@ Oral Specimen Collection Device.
The Oral Fluid DAT SQ Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.
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)
R
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110446
§ 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).