(101 days)
Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi- quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi- quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of propoxyphene use or abuse and do not measure a level of toxicity.
Propoxyphene Plus 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 judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The Roche ONLINE DAT Propoxyphene Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
The ONLINE DAT Propoxyphene Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Propoxyphene drug derivative is conjugated to microparticles in solution, and propoxyphene polyclonal antibody (goat) is solubilized in buffer. In the absence of sample drug, free antibody binds to drug- microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free 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 document is a 510(k) summary for the Roche ONLINE DAT Propoxyphene Plus assay, not a study report. Therefore, it does not contain detailed information about specific studies, acceptance criteria, or performance data in the format typically found in a study.
However, based on the information provided, I can infer some aspects and highlight what is missing.
Here's an attempt to answer your questions by extracting what's available and noting what's explicitly absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in a quantitative table or provide detailed performance metrics like sensitivity, specificity, accuracy, or correlation coefficients. It primarily focuses on demonstrating substantial equivalence to a predicate device.
What is mentioned:
The assay is for the qualitative and semi-quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. This cutoff would be a key parameter for any performance evaluation.
2. Sample size used for the test set and the data provenance
- Sample size: Not specified in the 510(k) summary.
- Data provenance: Not specified. It's likely involved a combination of spiked samples and potentially clinical urine specimens, but the origin (e.g., country, retrospective/prospective) is not disclosed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The ground truth for drug assays typically involves analytical methods (like GC/MS) rather than expert interpretation of results, so "experts" in the sense of clinicians reading images would not be applicable.
4. Adjudication method for the test set
- Not applicable as the ground truth for drug assays relies on objective analytical methods.
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
- No. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting images. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The device itself is a standalone analytical system. Its performance is evaluated based on its ability to correctly identify the presence or absence of propoxyphene in urine samples relative to a gold standard analytical method. There is no human "in the loop" for the primary function of the assay.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Analytical Gold Standard: For drug assays like this, the ground truth is typically established by a highly specific and sensitive reference method, such as Gas Chromatography/Mass Spectrometry (GC/MS). The "Indications for Use" section explicitly states: "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
8. The sample size for the training set
- Not specified. The development of an immunoassay like this would involve extensive research and development; however, the term "training set" in the context of machine learning is not directly applicable here. The assay is "trained" in the sense that its components (antibodies, microparticles) are optimized, but this isn't data-driven training in the modern AI sense.
9. How the ground truth for the training set was established
- Not applicable in the context of "training set" as understood today for AI. The "ground truth" for optimizing the assay components during development would have been based on known concentrations of propoxyphene and its metabolites, verified by analytical methods like GC/MS.
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MAR í í 2005
| 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. |
|---|---|
| 1) Submitter name, address, contact | Roche Diagnostics9115 Hague Rd.Indianapolis, IN 46250(317) 521-7637Contact Person: Kerwin Kaufman |
| Date Prepared: November 29, 2004 | |
| 2) Device name | Proprietary name: ONLINE DAT Propoxyphene PlusCommon name: Propoxyphene test systemClassification name: Enzyme immunoassay, Propoxyphene |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Propoxyphene assay (K983700). |
510(k) Summary
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510(k) Summary, Continued
The Roche ONLINE DAT Propoxyphene Plus assay is an in vitro diagnostic 4) Device test for the qualitative and semi-quantitative detection of propoxyphene and Description its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.
Principal of procedure
The ONLINE DAT Propoxyphene Plus assay is based on the kinetic interaction of microparticles in a solution (KIMS technology). Assay measurement is based on measurable changes in light transmission related to the interaction of microparticles in a solution and the sample drug of interest, if present. Propoxyphene drug derivative is conjugated to microparticles in solution, and propoxyphene polyclonal antibody (goat) is solubilized in In the absence of sample drug, free antibody binds to drugbuffer. microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.
When a urine sample contains the drug in question, this drug competes with the particle-bound drug derivative for free 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.
Negative Sample drug-conjugated microparticles + free antibody = particle aggregates (↑ absorbance)
Positive Sample
sample drug + drug-conjugated microparticle = particle aggregation inhibited drug-conjugated microparticles + free antibody = particle aggregates
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510(k) Summary, Continued
| 5.) IntendedUse | Propoxyphene Plus is an in vitro diagnostic test for the qualitative and semi- quantitative detection of propoxyphene and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 300 ng/ml. Semi- quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. |
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| 6.) Comparisonto the PredicateDevice | The Roche ONLINE DAT Propoxyphene Plus is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Propoxyphene (K983700). |
| Both the new and predicate device assays are based on the kinetic interaction of microparticles in a solution (KIMS technology). Differences between this application and the predicate cleared assay include: a change in the accelerant / activator contained in the diluent solution used to make the antibody working solution (R1 reagent),and use of new (previously cleared) calibrators and unassayed controls. |
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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR í 1 2005
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
K043303 Re:
Trade/Device Name: ONLINE DAT Propoxyphene Plus Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: Class II Product Code: JXN Dated: February 15, 2005 Received: February 17, 2005
Dear Mr. Kaufman:
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 docs 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will allow you to ocgin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The PDA Inding of bassance of the may be ice and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, of Jr If you desire specific information acour the uppervaility, please contact the Office of In of questions on the promotion and Safety at (240)276-0484. Also, please note the v in o Dagliostic Device Device in reference to premarket notification" (21CFR Part 807.97). regulation entitled, "Misoranung of Teisenn your responsibilities under the Act from the You may outlined there general monitational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, D.V.M. 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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Indications for Use
510(k) Number (if known): K043303
ONLINE DAT Propoxyphene Plus Device Name:
Indications For Use:
.
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quantitative detection of propoxyphene and its metabolites in humi quantitative detection of propoxypliene and its mecabs at a cutiff of 300 ng/ml.
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Semi-quantitative test results may be obtained that permit laboratories to assess Semi-quantitative test results may be obtained that portunents obtained
assay performance as part of a quality control program. Measurements obtained assay performance as part of a quality control program. These in the end of this device and do
by this device are used in the diagnosis of propoxyphene use or abuse and do
r not measure a level of toxicity.
Propoxyphene Plus provides only a preliminary analytical test result. A more
t the provides on the the closed in order to order to obtain a confirme Propoxyphene Plus provides only a preilinniary and in order to obtain a confirmed
specific alternate chemical method must be used in order to obtain is the specific alternate chemical method must be assectrometry (GC/MS) is the analytical result. Gas chromatographymiass spotion and professional judgment
preferred confirmatory method. Clinical consideration and professional judgment preferred confirmatory metnod. Cillilical consideration and provide and the profits.
should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
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Office of In Vitm Dlagnostic
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).