(68 days)
No
The summary describes a standard in vitro diagnostic test for detecting a substance in urine using automated clinical chemistry analyzers. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The description focuses on the chemical assay and its use on existing automated platforms.
No
This device is described as an "in vitro diagnostic test" for detecting methadone in human urine and is used on "automated clinical chemistry analyzers." Its purpose is diagnostic (detection of a substance), not therapeutic (treating or alleviating a medical condition).
Yes
This device is an in vitro diagnostic test designed to detect methadone in human urine, which is used to diagnose the presence of the substance.
No
The device is an in vitro diagnostic test for chemical analysis of urine, which inherently involves reagents and hardware components (automated clinical chemistry analyzers). The description does not indicate it is solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states it is an "in vitro diagnostic test".
- Device Description: Also explicitly states it is an "in vitro diagnostic test".
- Anatomical Site: Specifies "human urine", which is a biological sample tested in vitro (outside the body).
- Intended User/Care Setting: Mentions "automated clinical chemistry analyzers", which are instruments used in a laboratory setting for in vitro testing.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The ONLINE DAT II Methadone II is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration 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.
Product codes
DJR
Device Description
The ONLINE DAT II Methadone assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/ml.
Principal of procedure
The ONLINE DAT II Methadone 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.
When a urine sample containing the drug in question is present, 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.
As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).
0
)CO2/505
JUL 16 2002
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 Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 521-7637 | |
| Contact Person: Kerwin Kaufman | |
| Date Prepared: May 8, 2002 | |
| 2) Device name | Proprietary name: ONLINE DAT II Methadone II |
| Common name: Methadone Test System | |
| Classification name: Enzyme immunoassay, methadone | |
| 3) Predicate device | We claim substantial equivalence to the currently marketed Abuscreen OnLine Methadone assay (K983703). |
Continued on next page
1
510(k) Summary, Continued
The ONLINE DAT II Methadone assay is an in vitro diagnostic test for the 4) Device Description qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration of 300 ng/ml.
Principal of procedure
The ONLINE DAT II Methadone II assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light In the absence of sample drug, soluble drug-polymer transmission. conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates.
When a urine sample containing the drug in question is present, 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.
As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. Conversely, 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-polymer conjugate + antibody-bound microparticle = particle aggregates (↑ absorbance)
Positive Sample
sample drug + antibody-bound microparticle = particle aggregation inhibited drug-polymer conjugate + antibody bound microparticle = particle aggregates
Continued on next page
2
510(k) Summary, Continued
ワ .
| 5.) Intended
Use | The ONLINE DAT II Methadone II is an in vitro diagnostic test for the
qualitative and semi-quantitative detection of methadone in human urine on
automated clinical chemistry analyzers at a cutoff concentration 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. |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.) Comparison
to the Predicate
Device | The Roche ONLINE DAT II Methadone II assay 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 Methadone (K983703).
The Roche ONLINE DAT II Methadone II assay utilizes a modified KIMS
technology relative to the currently marketed Abuscreen OnLine Methadone
assay. Differences between this application and the cleared assay include:
use of a methadone monoclonal antibody attached to
microparticles in solution, a soluble drug-polymer conjugate, and use of new calibrators and unassayed controls. |
and the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contribution of the consis
,
3
Image /page/3/Picture/0 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with flowing lines beneath them.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # # Rockville MD 20850
UUL 1 6 2002
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K021505
Trade/Device Name: Roche Diagnostics ONLINE DAT II Methadone II Regulation Number: 21 CFR 862.3620 Regulation Name: Methadone test system Regulatory Class: Class II Product Code: DJR Dated: May 8, 2002 Received: May 9, 2002
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 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your 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.
。Page 2 26 ・・・ (20) 10月には、 ・
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact.the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmamain.html".
Sincerely yours,
Steven Butman
此刻意事 不要有意思了主要感情的意思想
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement ის შეწყვილების გამოყვარი სახლეობა სამარტი გადავის მწვევა მარტი სამხრეთ მართლები მარტი სამხრეთ მართლები მარტი სამ
彩必赢彩
ాన్స్ స్టేష్
| 510(k) Number (if known): | K021505 |
|---|---|
| Device Name: | Roche Diagnostics ONLINE DAT II Methadone II |
| Indications for Use: | An in vitro diagnostic test for the qualitative and semi-quantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration 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. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | V OR Over-the-Counter Use ______ |
|---|---|
| (Optional format 1-2-96) |
Sean Cooper
(Division Sign Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number ____________________________________________________________________________________________________