(135 days)
No
The device description details a homogenous enzyme immunoassay based on recombinant DNA technology and spectrophotometric measurement. There is no mention of AI or ML in the intended use, device description, or the "Mentions AI, DNN, or ML" section. The mechanism of action is purely biochemical.
No
The device is an in vitro diagnostic (IVD) assay designed to detect the presence of buprenorphine in human urine. It is used for screening purposes and generates analytical test results, rather than providing direct therapeutic treatment to a patient.
Yes
Explanation: The device is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of buprenorphine in human urine. It is explicitly indicated for use in detecting the presence of buprenorphine, which is a diagnostic purpose. The text "The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result" indicates it is part of a diagnostic process, even if not the final confirmatory step.
No
The device description clearly outlines a chemical assay that utilizes recombinant DNA technology and spectrophotometry to detect buprenorphine in urine. This involves physical reagents and a measurement process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative or semi-quantitative determination of the presence of buprenorphine in human urine." This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Sample Type: The device is designed to be used with "human urine," which is a biological specimen.
- Purpose: The purpose is to detect the presence of a substance (buprenorphine) in the sample, which is a diagnostic activity.
- Device Description: The description details the biochemical reactions and measurement methods used to analyze the sample, which are characteristic of an in vitro diagnostic assay.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K001178) and the name "CEDIA DAU 6-Acetylmorphine Assay" strongly indicates that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of the presence of buprenorphine in human urine at cutoff concentration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The CEDIA® Buprenorphine calibrators are used to calibrate the CEDIA® Buprenorphine Assay in human urine.
The CEDIA® Buprenorphine controls are used to qualify the CEDIA® Buprenorphine Assay in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
Product codes
DJG, DLJ, LAS
Device Description
The CEDIA® Buprenorphine Assay uses recombinant DNA technology (US Patent No. The CDDA - Buptellorpinne Assay assurve immunoassay system. The assay is 4706929) 10 produce a unique nomegatiosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These Into two macive ragments no, chily to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive In the assuy, and you in the bankibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyments free to form active enzyme. If It onluds to antibody, Italibedy binds to analyte conjugated on the inactive andryle is not probent in eassociation of inactive p-galactosidase fragments, and no active fragment, innonting the reassociation ve enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
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
§ 862.3650 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
SECTION II
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number:
Submitter:
Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Contact Person:
David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212
Preparation Date:
February 6, 2004
Device Information:
| Device Classification Name: | Radioimmunoassay, Buprenorphine |
|---|---|
| Common/Usual Name: | Buprenorphine Immunoassay Test System |
| Proprietary Name: | CEDIA® Buprenorphine Assay |
| Regulation Number: | 21 CFR§862.3650 |
| Regulatory Name: | Buprenorphine test system |
| Product Code: | DJG |
| Regulatory Class: | Class II |
Predicate Devices:
The CEDIA® Buprenorphine Assay is substantially equivalent to other CEDIA test systems cleared by FDA, e.g., the CEDIA DAU 6-Acetylmorphine Assay (K001178), and GC/MS for its stated intended use.
1
Device Description:
The CEDIA® Buprenorphine Assay uses recombinant DNA technology (US Patent No. The CDDA - Buptellorpinne Assay assurve immunoassay system. The assay is 4706929) 10 produce a unique nomegatiosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These Into two macive ragments no, chily to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, analyte in the sample competes with analyte conjugated to one inactive In the assuy, and you in the bankibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyments free to form active enzyme. If It onluds to antibody, Italibedy binds to analyte conjugated on the inactive andryle is not probent in eassociation of inactive p-galactosidase fragments, and no active fragment, innonting the reassociation ve enzyme formed and resultant absorbance change are directly proportional to the amount of drug present in the sample.
Intended Use:
The CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative The OEDIT - Bapterler presence of buprenorphine in human urine at or some qualitiration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. alter hatre energraphy /mass spectrometry (GC/MS) is the preferred confirmatory Gas caromator rapay reofessional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
2
Comparison to Predicate Device(s):
The CEDIA® Buprenorphine Assay is substantially equivalent to other CEDIA test The CEDIA "Buprehotphine Assay is Subblantany Squares
systems cleared by FDA, e.g., the CEDIA DAU 6-Acetylmorphine Assay (K001178), and GC/MS for its stated intended use.
| Device
Characteristics | Subject Device | Predicate Device(s)
GC/MS and K001178 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The CEDIA® Buprenorphine assay is
a homogenous enzyme immunoassay
for qualitative or semi-quantitative
determination of the presence of
buprenorphine in human urine at
cutoff concentration of 5 ng/mL. The
assay provides a simple and rapid
analytical screening procedure to
detect buprenorphine in human urine. | The CEDIA® DAU 6-
Acetylmorphine Assay is a
homogenous enzyme
immunoassay for the in vitro
qualitative or semi-quantitative
determination of 6-
Acetylmorphine in human urine
on automated clinical chemistry
analyzers. Measurements are
used as an aid in the detection
of heroin use or overdose. |
| Analyte | Buprenorphine | 6-AM |
| Matrix | Urine | Urine |
| Calibrator
Form | Liquid | Liquid |
| Calibrator
Levels | Five (5) Levels (0, 5, 20, 50 and
75 ng/mL) | Four (4) Levels (0,10,20 and 50
ng/mL) |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date |
| Stability | Until expiration date noted on
vial label and Package Insert
for Kit and reconstituted
reagents | Until expiration date noted on
vial label. |
Summary:
The information provided in this pre-market notification demonstrates that the CEDIA® Buprenorphine Assay is substantially equivalent to other CEDIA test system and GC/MS. Dubstantial equivalence was demonstrated through comparison of intended use and Substantial equitation was emercially available and analytical predicate devices. The physiour properties to the commens.com provides reasonable assurance that the CEDIA® Buprenorphine Assay is safe and effective for its stated intended use.
CEDIA® is a registered trademark of Roche Diagnostics.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 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-like figure with three curved lines representing its wings or body. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES INC."
JUN 2 3 2004
David Casal, Ph.D David Casal, I m.b.
Vice-President, Clinical, Regulatory and Quality Affairs Microgenics Corp. 46360 Fremont Blvd. Fremont, CA 94538
K040316 Re:
Trade/Device Name: CEDIA® Buprenorphine Assay CEDIA® Buprenorphine Calibrators CEDIA® Buprenorphine Controls
Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG, DLJ, LAS, Dated: May 6, 2004 Received: May 10, 2004
Dear Dr. Casal:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use stated in the encreate) to trg. 25 the enactment date of the Medical Device Amendments, or to conninered pror to they 2011-31-11 de necs that have been recuire approval of a premarket approval application (PMA). allu Cosmetle Act (1107 that ac not requesable to the general controls provisions of the Act. The r ou may, therefore, mainer of the Act include requirements for annual registration, listing of general controls provisions of the tice, 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 your device is elassified (66 and controls. Existing major regulations affecting your device It may be subject to such additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can be found in Title Drouncements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dr is issuance or wou device complies with other requirements of the Act that I DA has made a acternations administered by other Federal agencies. You must of any I cuchares and regaranents, including, but not limited to: registration and listing (21 Comply with an the Free Frequent Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin maxioning of substantial equivalence of your device to a legally premarket nonitication: "The PDF misms of cation 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, II you desire specific information as advertising of your device, please contact the Office of of questions on the promotion and Safety at (301) 594-3084. Also, please note the In Ville Dragiosale De 1600 Breference to premarket notification" (21CFR Part 807.97). regulation chitica, "Misolunding of responsibilities under the Act from the I bu inay other general mormational 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/dsma/dsmamain.html.
Sincerely yours,
Sean M. Cooper, MS, DVM.
Yean 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
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K040316
CEDIA® Buprenorphine Assay Device name: CEDIA® Buprenorphine Calibrators CEDIA® Buprenorphine Controls
Indications for Use:
The CEDIA® Buprenorphine assay is a homogenous enzyme immunoassay for qualitative or semi-quantitative determination of the presence of buprenorphine in human urine at cutoff concentration of 5 ng/mL. The assay provides a simple and rapid analytical screening procedure to detect buprenorphine in human urine.
The CEDIA® Buprenorphine calibrators are used to calibrate the CEDIA® Buprenorphine Assay in human urine.
The CEDIA® Buprenorphine controls are used to qualify the CEDIA® Buprenorphine Assay in human urine.
The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.
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 CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Silberto Ortiz
Division Sign-Off
Division Sign-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040316
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