(47 days)
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Not Found
No
The device description and performance studies focus on the chemical composition and analytical performance of calibrators for drug assays, with no mention of AI or ML technologies.
No
The device is a calibrator for drug assays, used to set the measurement scale for automated clinical chemistry analyzers, not to directly treat or diagnose a disease.
No
The device is a calibrator, used to calibrate diagnostic devices (CEDIA® DAU Assays), not a diagnostic device itself.
No
The device description clearly states it is a physical product (calibrators) made from human urine, drugs of abuse, and a preservative, intended for use with automated clinical chemistry analyzers. It is not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are for the "calibration of qualitative and semiquantitative CEDIA® DAU Assays on automated clinical chemistry analyzers." This indicates that the device is used in vitro (outside the body) to calibrate tests that analyze biological samples (urine) for the presence of drugs of abuse.
- Device Description: The description details the composition of the calibrators, which are made using "drug free human urine" and various drugs of abuse. This confirms that the device is a reagent or material used in a laboratory setting for diagnostic purposes.
- Performance Studies: The performance studies describe the analysis of the calibrators using GC/MS, a common analytical technique used in clinical laboratories for confirming the concentration of substances in biological samples. This further supports the device's role in a diagnostic process.
- Predicate Device: The mention of a "Predicate Device" which is "Methadone Metabolite Urine Calibrators manufactured by Diagnostic Reagents, Inc." strongly suggests that this device is being compared to another device already classified as an IVD.
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. In this case, the information provided is for the calibration of assays used to detect drugs of abuse in urine, which is a diagnostic purpose.
N/A
Intended Use / Indications for Use
The CEDIA ® DAU Multi-Drug Calibrators are used for the calibration of qualitative and semiquantitative CEDIA ® DAU assays in human urine on automated clinical chemistry analyzers.
Product codes (comma separated list FDA assigned to the subject device)
DKB
Device Description
The CEDIA ® DAU Multi-Drug Calibrators are manufactured using drug free human urine, various drugs of abuse and a preservative. At this time, the drugs of abuse are d-methamphetamine, secobarbital, nitrazepam, morphine, benzoylecgonine, phencyclidine, and EDDP. The drug raw materials are obtained from a commercially available source and are spiked appropriately into the calibrator matrix to obtain the correct calibrator concentration levels. The calibrators are in-process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have had values confirmed using GC/MS by 3 laboratories.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
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Intended User / Care Setting
automated clinical chemistry analyzers.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CEDIA® DAU Multi-Drug Calibrators were analyzed for EDDP by GC/MS in 2 separate laboratories. The results of the study were as follows:
Calibrator: Primary Cutoffs, Target [EDDP] ng/mL: 100, Mean [EDDP] ng/mL: 103.1
Calibrator: Secondary Cutoffs, Target [EDDP] ng/mL: 100, Mean [EDDP] ng/mL: 101.0
Calibrator: Intermediate, Target [EDDP] ng/mL: 500, Mean [EDDP] ng/mL: 496.3
Calibrator: High, Target [EDDP] ng/mL: 2000, Mean [EDDP] ng/mL: 2033
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Methadone Metabolite Urine Calibrators manufactured by Diagnostic Reagents, Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.
0
| APR 21 1998 | 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: March 2, 1998 |
| 2) Device name | Proprietary name: CEDIA ® DAU Multi-Drug Calibrators |
|---|---|
| Common name: Drug of Abuse calibrators for use in the calibration of | |
| CEDIA ® DAU Assays | |
| Classification name: Calibrators, Drug Mixture |
| 3) Predicate device | We claim substantial equivalence to the Methadone Metabolite Urine
Calibrators manufactured by Diagnostic Reagents, Inc. |
| --------------------- | ----------------------------------------------------------------------------------------------------------------------------- |
|---|
Continued on next page
1
510(k) Summary, Continued
| 4) Device Description | The CEDIA ® DAU Multi-Drug Calibrators are manufactured using drug free human urine, various drugs of abuse and a preservative. At this time, the drugs of abuse are d-methamphetamine, secobarbital, nitrazepam, morphine, benzoylecgonine, phencyclidine, and EDDP. The drug raw materials are obtained from a commercially available source and are spiked appropriately into the calibrator matrix to obtain the correct calibrator concentration levels. The calibrators are in-process checked and quality controlled against in-house reference calibrators (prepared using a similar procedure) which have had values confirmed using GC/MS by 3 laboratories. |
|---|---|
| 5) Intended use | The CEDIA ® DAU Multi-Drug Calibrators are used for the calibration of qualitative and semiquantitative CEDIA ® DAU assays in human urine on automated clinical chemistry analyzers. |
Continued on next page
2
510(k) Summary, Continued
6) Comparison to predicate device
The Boehringer Mannheim Modified CEDIA® DAU Multi-Drug Calibrators are substantially equivalent to other products in commercial distribution (8) DAU Multiintended for similar use. Most notably, the Modified CEDIA Drug Calibrators with the addition of EDDP are substantially equivalent to the Methadone Metabolite Urine Calibrators manufactured by Diagnostic Reagents Inc. (DRI).
| Feature | DRI EDDP Urine
Calibrators | Modified CEDIA®
DAU Multi-Drug
Calibrators |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Matrix | Human Urine | Human Urine |
| Preservative | Sodium Azide | Sodium Azide |
| Storage conditions | 2-8 ° C | 2-8 ° C |
| Ease of use | Ready to use | Ready to use |
| EDDP concentration: | | |
| Cutoff calibrator | 300 ng/ml | 100 ng/ml |
| Intermediate Calibrator | 1000 ng/ml | 500 ng/ml |
| High Calibrator | 2000 ng/ml | 2000 ng/ml |
| Calibrator composition | Single analyte | Multiple analytes |
| Intended Use | For in vitro diagnostic
use for the calibration of
enzyme immunoassay
for detection of
methadone metabolites
in human urine. | For use as calibrators in
the CEDIA DAU
qualitative and
semiquantitative
determination of drugs
of abuse in human urine
on automated clinical
chemistry analyzers. |
Continued on next page
3
510(k) Summary, Continued
Performance Characteristics:
- Comparison to predicate device, (cont.)
The CEDIA® DAU Multi-Drug Calibrators were analyzed for EDDP by GC/MS in 2 separate laboratories. The results of the study were as follows:
| Calibrator | Target [EDDP]
ng/mL | Mean [EDDP]
ng/mL |
|-------------------|------------------------|----------------------|
| Primary Cutoffs | 100 | 103.1 |
| Secondary Cutoffs | 100 | 101.0 |
| Intermediate | 500 | 496.3 |
| High | 2000 | 2033 |
4
Image /page/4/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 21 1998
Betsy Soares-Maddox . Manager, Regulatory Affairs and Quality Assurance Boehringer Mannheim Coporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K980853 CEDIA® DAU Multi-Drug Calibrators Requlatory Class: II Product Code: DKB Dated: March 2, 1998 Received: March 5, 1998
Dear Ms. Soares-Maddox:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 beqin 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 to
premarket notification" (21 CFR 807.97). Other general 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 Sitman
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 Multi-Drug Calibrators
Indications For Use:
The CEDIA® DAU Multi-Drug Calibrators are intended for the calibration of qualitative and semiquantitative CEDIA® DAU Assays on automated clinical chemistry andy zers.
| 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 of Clinical, Laboratory Devices
510(k) Number 980853