(135 days)
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.
The CEDIA® Buprenorphine Assay uses recombinant DNA technology (US Patent No. 4706929) to 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.
This 510(k) premarket notification (K040316) is for the CEDIA® Buprenorphine Assay, a homogenous enzyme immunoassay designed for the qualitative or semi-quantitative determination of buprenorphine in human urine. The information provided focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed data from a specific clinical study with acceptance criteria and device performance results. Instead, it relies on analytical comparisons and functional equivalence to other cleared devices.
Here's a breakdown of the requested information based on the provided text, with acknowledgments where specific details are not available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a typical table of acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) for a clinical study comparing the device against a ground truth standard in a test set. Instead, substantial equivalence is claimed based on comparing intended use and physical properties to existing predicate devices, combined with the assumption that similar analytical characteristics will yield similar performance for the stated intended use.
The document states: "The CEDIA® Buprenorphine Assay is substantially equivalent to other CEDIA test system and GC/MS. Substantial equivalence was demonstrated through comparison of intended use and physical properties to the commercially available and analytical predicate devices. The information provides reasonable assurance that the CEDIA® Buprenorphine Assay is safe and effective for its stated intended use."
The primary "acceptance criteria" presented are related to the analytical characteristics and intended use being comparable to the predicate devices. The "reported device performance" is essentially that it functions similarly to and provides comparable results to the predicate devices, particularly GC/MS for confirmation.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Qualitative or semi-quantitative determination of buprenorphine | Performs qualitative or semi-quantitative determination of buprenorphine |
| Detects buprenorphine in human urine at cutoff concentration 5 ng/mL | Detects buprenorphine in human urine at cutoff concentration 5 ng/mL |
| Provides a simple and rapid analytical screening procedure | Provides a simple and rapid analytical screening procedure |
| Substantial equivalence to predicate devices (CEDIA DAU 6-Acetylmorphine Assay and GC/MS) in intended use, matrix, and analytical principles. | Demonstrated substantial equivalence in intended use, analyte, matrix, calibrator form, storage, and stability to predicate devices. |
| Effective for its stated intended use | Provides "reasonable assurance that the CEDIA® Buprenorphine Assay is safe and effective for its stated intended use" based on substantial equivalence. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not specify a sample size for a test set of clinical samples. The submission focuses on analytical characteristics and comparison to predicate devices rather than a direct clinical performance study with a test set of patient samples. Therefore, information on data provenance (country of origin, retrospective/prospective) for a test set is not available.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since a specific test set of clinical samples and a corresponding clinical study are not detailed, there is no information provided on the number of experts or their qualifications used to establish ground truth for such a set. The "ground truth" reference in this context is the predicate method, Gas Chromatography/Mass Spectrometry (GC/MS), which is mentioned as the preferred confirmatory method.
4. Adjudication Method for the Test Set
As there is no described test set or clinical study, there is no information on an adjudication method.
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
This device is an immunoassay for drug detection in urine, not an imaging device or AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not performed or described.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The CEDIA® Buprenorphine Assay is a standalone laboratory assay (an immunoassay) that provides a preliminary analytical test result. It operates as an algorithm (chemical reaction leading to a spectrophotometric reading to determine the presence and quantity) without human-in-the-loop performance in the sense of AI interpretation. The output is a quantitative or qualitative reading, which then requires human clinical and professional judgment.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The document implicitly uses Gas Chromatography/Mass Spectrometry (GC/MS) as the gold standard or "ground truth" for confirming analytical results for buprenorphine. The text states: "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."
8. The Sample Size for the Training Set
The concept of a "training set" in the context of machine learning or AI is not applicable to this immunoassay device. The device's performance is based on its chemical and biological principles, not on a machine learning model trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the typical AI/ML sense, this question is not applicable. The underlying principles of the immunoassay are based on established antibody-antigen reactions and enzymatic activity, which don't require machine learning training data.
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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.
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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.
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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.
| DeviceCharacteristics | Subject Device | Predicate Device(s)GC/MS and K001178 |
|---|---|---|
| Intended Use | The CEDIA® Buprenorphine assay isa homogenous enzyme immunoassayfor qualitative or semi-quantitativedetermination of the presence ofbuprenorphine in human urine atcutoff concentration of 5 ng/mL. Theassay provides a simple and rapidanalytical screening procedure todetect buprenorphine in human urine. | The CEDIA® DAU 6-Acetylmorphine Assay is ahomogenous enzymeimmunoassay for the in vitroqualitative or semi-quantitativedetermination of 6-Acetylmorphine in human urineon automated clinical chemistryanalyzers. Measurements areused as an aid in the detectionof heroin use or overdose. |
| Analyte | Buprenorphine | 6-AM |
| Matrix | Urine | Urine |
| CalibratorForm | Liquid | Liquid |
| CalibratorLevels | Five (5) Levels (0, 5, 20, 50 and75 ng/mL) | Four (4) Levels (0,10,20 and 50ng/mL) |
| Storage | 2°C to 8°C until expiration date | 2°C to 8°C until expiration date |
| Stability | Until expiration date noted onvial label and Package Insertfor Kit and reconstitutedreagents | Until expiration date noted onvial 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.
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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
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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
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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
Page 1 of
§ 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).