(63 days)
Not Found
No
The device description details a chemical assay based on kinetic interaction of microparticles and light transmission, which is a standard laboratory technique and does not involve AI/ML. There are no mentions of AI, ML, or related terms in the provided text.
No.
The device is an in vitro diagnostic test used to detect morphine and its metabolites in human urine, which is for diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" states that it is "An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine." This explicitly identifies it as a diagnostic device.
No
The device description clearly indicates it is an in vitro diagnostic test based on a kinetic interaction of microparticles in a solution (KIMS) and measured by changes in light transmission. This involves physical reagents and a chemical reaction, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "in vitro diagnostic test".
- Device Description: The "Device Description" also refers to it as an "in vitro diagnostic test".
- Sample Type: It analyzes "human urine", which is a biological sample taken from the body.
- Purpose: It is used for the "qualitative and semi-quantitative detection of morphine and its metabolites", which is a diagnostic purpose (identifying the presence and approximate amount of a substance in a sample).
- Setting: It is intended for use in "laboratories", a typical setting for IVD testing.
N/A
Intended Use / Indications for Use
An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 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
DJG
Device Description
The Abuscreen OnLine Opiates 300/2000 assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL
Principal of procedure
The Abuscreen OnLine Opiates 300/2000 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 drug 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.
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
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.
Roche Diagnostics Corporation 1) Submitter name, address, 9115 Hague Rd. contact Indianapolis, IN 46250 (317) 521-7637
Contact Person: Kerwin Kaufman
Date Prepared: October 18, 2001
Proprietary name: Abuscreen OnLine Opiates 300/2000 2) Device name
Common name: Opiates Test System
Classification name: Enzyme immunoassay, opiates
- Predicate device
We claim substantial equivalence to the currently marketed Abuscreen OnLine II Opiates 300/2000 assay (K974840).
Continued on next page
1
- Device Description The Abuscreen OnLine Opiates 300/2000 assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 ng/mL
Principal of procedure
The Abuscreen OnLine Opiates 300/2000 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 drug 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.
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
The Abuscreen OnLine Opiates 300/2000 assay is an in vitro diagnostic test 5.) Intended for the qualitative and semi-quantitative detection of morphine and its Use metabolites in buman urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 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 Abuscreen OnLine Opiates 300/2000 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 II Opiates 300/2000 (K974840).
The Abuscreen OnLine Opiates 300/2000 assay utilizes the same reagent formulation as the currently marketed Abuscreen OnLine II Opiates 300/2000 assay (K974840). Differences between this application and the cleared assay include:
- addition of a 300 ng/mL semi-quantitative cutoff claim, and ●
- application to the Hitachi 900 series and Modular series of . analyzers.
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 stylized depiction of an eagle or bird with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Mr. Kerwin Kaufman Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K013482
Trade/Device Name: Roche Diagnostics Abuscreen OnLine Opiates 300/2000 Regulation Number: 21 CFR 862.3650 Regulation Name: Lead test system Regulatory Class: Class II Product Code: DJG Dated: October 18, 2001 Received: October 19, 2001
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.
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Page 2 -
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 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/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
| 510(k) Number (if known): | K013482 |
|---|---|
| Device Name: | Roche Diagnostics Abuscreen OnLine Opiates 300/2000 |
| Indications for Use: | An in vitro diagnostic test for the qualitative and semi-quantitative detection of morphine and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 300 and 2000 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) | ✓ OR Over-the-Counter Use ______ |
|---|---|
| (Optional format 1-2-96) |
(Division Sign-Off)
Division Clinical Laboratory Devices
510(k) Number: K013482