(89 days)
Not Found
No
The summary describes a standard enzyme immunoassay and does not mention any AI or ML components.
No
The device aids in diagnosis and treatment by measuring EDDP in urine, which is an in vitro diagnostic function, not a direct therapeutic intervention.
Yes.
The "Intended Use / Indications for Use" section states that "Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose." This explicitly indicates a diagnostic purpose.
No
The device is described as a "homogeneous enzyme immunoassay" and details performance characteristics related to chemical reactions and concentrations, indicating it is a laboratory assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "for the in vitro qualitative and semiquantitative determination of EDDP in human urine". The phrase "in vitro" is a key indicator of an IVD, meaning it's used outside of the living body.
- Device Description: It describes a "Homogeneous enzyme immunoassay for the determination of EDDP levels in urine," which is a common type of assay used in IVD testing.
- Anatomical Site: The sample being tested is "human urine," which is a biological specimen analyzed in IVD tests.
- Intended User/Care Setting: The device is used on "automated clinical chemistry analyzers," which are standard equipment in clinical laboratories where IVD testing is performed.
- Performance Studies: The document includes details about performance characteristics like precision, sensitivity, accuracy, and specificity, which are typical evaluations for IVD devices to demonstrate their reliability for diagnostic purposes.
- Predicate Device(s): The mention of a predicate device (K931780; Methadone Metabolite Enzyme Immunoassay) indicates that this device is being compared to a previously cleared IVD, a common practice in regulatory submissions for IVDs.
All of these factors strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CEDIA® DAU EDDP Assay is a homogeneous enzy me immunoassay for the in vitro qualitative and semiquantitative determination of EDDP in human urine on automated clinical chemistry analy zers. Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose.
Product codes
DJR
Device Description
Proprietary name: CEDIA ® DAU EDDP Assay
Common name: Homogeneous enzyme immunoassay for the determination of EDDP levels in urine.
Classification name: Methadone test system
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)
Comparison to predicate device:
Similarities:
- Both assays are for the qualitative and semi-quantitative determination of . EDDP levels in human urine.
- Both assays utilize a monoclonal antibody. .
- Both are enzyme immunoassays. .
- Both assays may be used on the same instrumentation. .
- Both assays have a similar assay range. .
Differences:
- The two assays have different cutoff concentrations. .
Performance Characteristics:
Precision:
CEDIA® DAU EDDP:
Intra assay:
- 75 ng/ml: N=21, %CV=1.1
- 100 ng/ml: N=21, %CV=1.0
- 125 ng/ml: N=21, %CV=1.3
Qualitative Sensitivity: 6.3 ng/mL (3 S.D.)
Rate Separation:
CEDIA® DAU EDDP:
- Negative Calibrator or Low Control to Cutoff (75-100 ng/mL): 19.4 mAU/min
- Cutoff to High Calibrator or Control (100-125 ng/mL): 13.2 mAU/min
Accuracy (100 ng/mL Cutoff):
- vs. DRI EIA: Relative Sensitivity 81.6%, Relative Specificity 95.1%
- vs. HPLC: Relative Sensitivity 95.4%, Relative Specificity 98.2%
Specificity (Conc. (ng/mL) / [EDDP] Obs. ng/ml / % Cross-reactivity):
- EDDP: 100 / 100 / 100
- EMDP: 200000 / 7.4 / 0.004
- Methadone: 600000 / 98.6 / 0.016
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 81.6% (vs. DRI EIA), 95.4% (vs. HPLC)
Relative Specificity: 95.1% (vs. DRI EIA), 98.2% (vs. HPLC)
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
BOEHRINGER MANN
.........
1/14/98 14:23 FAX 510 225 0654 BOEHRINGER MANN
MAY 26 1998 K980746
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 | Boehringer Mannheim Corporation
4300 Hacienda Drive
Pleasanton, CA 94588-2722
(510) 730-8240
Fax: (510) 225-0654 |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Betsy Soares-Maddox
Date Prepared: February 24, 1998 |
| 2) Device name | Proprietary name: CEDIA ® DAU EDDP Assay
Common name: Homogeneous enzyme immunoassay for the determination of EDDP levels in urine.
Classification name: Methadone test system |
| 3) Predicate device | We claim substantial equivalence to the Methadone Metabolite Enzyme Immunoassay (K931780) manufactured by Diagnostic Reagents, Inc. |
Continued on next page
Boehringer Mannheim Corporation CEDIA DAU EDDP Assay page 25
1
510(k) Summary, Continued
2
510(k) Summary, Continued
The Boehringer Mannheim CEDIA® DAU EDDP Assay is substantially 6) Comparison equivalent to other products in commercial distribution intended for similar to predicate use. Most notably it is substantially equivalent to the currently marketed device Methadone Metabolite Enzyme Immunoassay (K931780) manufactured by Diagnostic Reagents, Inc (DRI). The following table compares the CEDIA® DAU EDDP Assay with the
predicate device, Methadone Metabolite Enzyme Immunoassay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device in provided in attachment 6.
Similarities:
- Both assays are for the qualitative and semi-quantitative determination of . EDDP levels in human urine.
- Both assays utilize a monoclonal antibody. .
- Both are enzyme immunoassays. .
- Both assays may be used on the same instrumentation. .
- Both assays have a similar assay range. .
Differences:
- The two assays have different cutoff concentrations. .
Continued on next page
3
510(k) Summary, Continued
Performance Characteristics: 6) Comparison to predicate device, (cont.)
| Feature | DRI Methadone Metabolite EIA | CEDIA® DAU EDDP | ||||
|---|---|---|---|---|---|---|
| Precision | Intra assay | Intra assay | ||||
| Concentration Level | ||||||
| N | ||||||
| %CV | Negative | |||||
| 10 | ||||||
| 0.1 | 300 ng/ml | |||||
| 10 | ||||||
| 0.1 | 2000 ng/ml | |||||
| 10 | ||||||
| 0.3 | 75 ng/ml | |||||
| 21 | ||||||
| 1.1 | 100 ng/ml | |||||
| 21 | ||||||
| 1.0 | 125 ng/ml | |||||
| 21 | ||||||
| 1.3 | ||||||
| Qualitative | ||||||
| Sensitivity | 75 ng/mL (2 S.D.) | 6.3 ng/mL (3 S.D.) | ||||
| Rate Separation | ||||||
| Negative Calibrator | ||||||
| or Low Control to | ||||||
| Cutoff | 18 mAU/min | |||||
| (0-300 ng/mL) | 19.4 mAU/min | |||||
| (75-100 ng/mL) | ||||||
| Cutoff to High | ||||||
| Calibrator or Control | 81 mAU/min | |||||
| (300-2000 ng/mL) | 13.2 mAU/min | |||||
| (100-125 ng/mL) | ||||||
| Accuracy | 300 ng/mL Cutoff: | 100 ng/mL Cutoff: | ||||
| Relative Sensitivity | ||||||
| Relative Specificity | Not reported | |||||
| Not reported | vs. DRI EIA | |||||
| 81.6% | ||||||
| 95.1% | vs. HPLC | |||||
| 95.4% | ||||||
| 98.2% | ||||||
| Specificity | Concentration which gives a | |||||
| positive result (ng/mL) | Conc. | |||||
| (ng/mL) | [EDDP] | |||||
| Obs. ng/ml | % Cross- | |||||
| reactivity | ||||||
| EDDP | 300 | 100 | 100 | 100 | ||
| EMDP | 400 | 200000 | 7.4 | 0.004 | ||
| Methadone | 5000 | 600000 | 98.6 | 0.016 |
Boehringer Mannheim Corporation CEDIA DAU EDDP Assay page 28
4
Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a symbol. The symbol is a stylized representation of a bird or eagle, with three overlapping lines forming its body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
MAY 26 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Julie A. Smith Boehringer Mannheim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
K980746 Re: CEDIA® EDDP® Assay Requlatory Class: II DJR Product Code: Dated: April 24, 1998 Received: April 28, 1998
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਨਾ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact. the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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 for information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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
6
510(k) Number (if known): N/A
Device Name: CEDIA® DAU EDDP Assay
Indications For Use:
The CEDIA® DAU EDDP Assay is a homogeneous enzy me immunoassay for the in vitro qualitative and semiquantitative determination of EDDP in human urine on automated clinical chemistry analy zers. Measurements are used as an aid in the diagnosis and treatment of methadone use or overdose.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
510(k) Number _
(Division Sign-Off)
Division of Clinical Laboratory Devices