(40 days)
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 and treatment of barbiturate use or overdose. Barbiturates 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.
The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The 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. Secobarbital drug derivative is conjugated to microparticles in solution, and secobarbital polyclonal antibody (sheep) 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 text is a 510(k) Summary for a medical device called "ONLINE DAT Barbiturates Plus." It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with acceptance criteria, sample sizes, and expert reviews in the way typically seen for new diagnostic algorithms or AI-driven devices.
Therefore, many of the requested categories (e.g., number of experts, adjudication method, MRMC studies, training set details) are not applicable or not mentioned in this type of submission. This document describes an in vitro diagnostic assay, which typically relies on analytical performance studies (accuracy, precision, linearity, etc.) rather than clinical read studies with human experts.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with corresponding "reported device performance" in the context of clinical accuracy when read by humans, as this is an in vitro diagnostic test rather than an image-based AI or diagnostic decision support tool.
However, the core performance relates to its ability to detect barbiturates at a specific cutoff. The predicate device's performance, which is implicitly the benchmark for "acceptance criteria" for substantial equivalence, is:
- Cutoff: 200 ng/ml for qualitative and semi-quantitative detection of barbiturates in human urine.
The new device, ONLINE DAT Barbiturates Plus, also states its performance characteristic:
- "The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml."
Since the purpose of the 510(k) is to demonstrate substantial equivalence, the "acceptance criteria" are implied to be that the new device performs comparably to the predicate device, especially regarding its detection characteristics like the cutoff level. No specific sensitivity/specificity values are given for clinical performance, as this is a chemical assay.
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical samples or a human-read study. For an in vitro diagnostic assay, sample sizes would typically refer to the number of spiked samples, patient samples, or controls used in analytical studies (e.g., accuracy, precision, linearity, interference). This information is not provided in the summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable. This is an in vitro diagnostic assay. Ground truth for such assays is typically established through reference chemical methods (e.g., GC/MS) or by spiking known concentrations of the analyte into samples, not via expert consensus on clinical interpretation.
4. Adjudication method for the test set
Not Applicable. See point 3.
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 is an in vitro diagnostic assay, not an AI-assisted diagnostic imaging or decision support device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is an in vitro diagnostic assay designed to be run on automated clinical chemistry analyzers. Its performance is inherently "standalone" in the sense that the assay itself generates the result without human interpretive input beyond following laboratory procedures. The output is a preliminary analytical test result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
While not explicitly stated for this specific submission, for in vitro diagnostic assays like this, the "ground truth" for performance evaluation typically involves:
- Reference Chemical Methods: Such as Gas Chromatography-Mass Spectrometry (GC/MS) which is considered the gold standard for drug quantification.
- Known Concentrations: Samples spiked with precise, known quantities of barbiturates.
The 510(k) summary only mentions that "A more specific alternate chemical method must be used in order to obtain a confirmed analytical result," implying that the assay provides preliminary results, and a confirmatory method establishing "ground truth" would be separate.
8. The sample size for the training set
Not Applicable. This is an in vitro diagnostic assay, not a machine learning model that requires a "training set" in the typical sense of AI/ML. The assay formulation is developed through biochemical research and optimization, not data-driven model training.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
{0}------------------------------------------------
DEC 2, 9 2004
510(k) Summary
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 KaufmanDate Prepared: November 18, 2004 |
|---|---|
| 2) Device name | Proprietary name: ONLINE DAT Barbiturates PlusCommon name: Barbiturate test systemClassification name: Enzyme immunoassay, Barbiturate |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Barbiturates assay (K983698). |
Continued on next page
{1}------------------------------------------------
510(k) Summary, Continued
The Roche ONLINE DAT Barbiturates Plus assay is an in vitro diagnostic 4) Device Description test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 Barbiturates 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. Secobarbital drug derivative is conjugated to microparticles in solution, and secobarbital polyclonal antibody (sheep) 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.
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
Continued on next page
{2}------------------------------------------------
510(k) Summary, Continued
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-5.) Intended Use quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. The Roche ONLINE DAT Barbiturates Plus is substantially equivalent to 6.) Comparison to the Predicate other products in commercial distribution intended for similar use. Most Device notably, it is substantially equivalent to the currently marketed Roche Abuscreen OnLine Barbiturates (K983698). 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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 symbol of three human profiles facing right, with flowing lines representing movement or connection.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 9 2004
Mr. Kerwin Kaufman, MBA, M.T. (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road, P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K043211
Trade/Device Name: ONLINE DAT Barbiturates Plus Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate test system Regulatory Class: Class II Product Code: DIS Dated: November 18, 2004 Received: November 19, 2004
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{4}------------------------------------------------
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
petiry
Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
Indications for Use
510(k) Number (if known): K043211
Device Name: ONLINE DAT Barbiturates Plus
Indications For Use:
Barbiturates Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 and treatment of barbiturate use or overdose. Barbiturates 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.
Prescription Use (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 GDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
5100 K0432//
Page 1 of
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).