(24 days)
The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron. The CEDIA Digoxin Calibrators are used to determine drug concentrations.
The CEDIA Digoxin Calibrators are manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. The drug is appropriately spiked into the calibrator matrix to 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 been value assigned by comparison to the predicate device to ensure correct assay calibration.
The provided regulatory document describes the Boehringer Mannheim Corporation's CEDIA Digoxin Calibrators and their substantial equivalence to a predicate device. It does not contain information related to acceptance criteria, specific device performance statistics, or details of a study meeting such criteria with the level of detail requested in the prompt. The document is primarily a 510(k) summary for a diagnostic device, focusing on its intended use, comparison to a predicate, and performance characteristics in terms of method correlation and stability relative to the predicate.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the provided text.
However, I can extract the information that is present:
No specific acceptance criteria or detailed device performance statistics are provided in the document beyond a qualitative statement of equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The document only states:
- "Method Comparison: equivalent correlation between predicate device Multi-Calibrators and the CEDIA Digoxin Calibrators."
- "Stability: equivalent open vial and shelf-life stability performance to the predicate device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not available in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a calibrator for an in vitro diagnostic device, not an imaging or diagnostic AI device that would typically involve expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is a calibrator for an in vitro diagnostic device, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a calibrator for an in vitro diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the "equivalent correlation" or "equivalent stability" studies, but for calibrators, the "ground truth" would typically involve established reference methods or traceable standards for digoxin concentration. The document mentions "in-house reference calibrators (prepared using a similar procedure) which have been value assigned by comparison to the predicate device."
8. The sample size for the training set
Not applicable. This is not an AI/ML device that uses a training set.
9. How the ground truth for the training set was established
Not applicable.
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| JUL 24 1997 | |
|---|---|
| -- | ------------- |
| BOEHRINGER MANNHEIM CORPORATION | 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.Submittername,address,contact | Boehringer Mannheim Corporation2400 Bisso LaneConcord, CA 94524-4117(510) 674-0690 extension 8413Fax number: (510) 687-1850Contact Person: Yvette LloydDate Prepared: June 27, 1997 |
|---|---|
| 2.Device name | Proprietary name: CEDIA Digoxin CalibratorsCommon name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA Digoxin II assay.Classification name: Calibrators, drug mixture |
| 3.Predicatedevice | The Boehringer Mannheim CEDIA Digoxin Calibrators are substantially equivalent to the CEDIA Cardiac TDM Multi-Calibrators (K962269). |
| 4.DeviceDescription | The CEDIA Digoxin Calibrators are manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. The drug is appropriately spiked into the calibrator matrix to 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 been value assigned by comparison to the predicate device to ensure correct assay calibration. |
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Summary, Continued
Image /page/1/Picture/1 description: The image shows a logo for Boehringer Mannheim. The logo consists of a black square with the word "mannheim" written vertically along the left side. Inside the square is a white circle with the word "boehringer" written horizontally in the center.
| 5.Intended use | The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin IIassay on the Beckman Synchron. |
|---|---|
| 6.Comparisonto predicatedevice | The Boehringer Mannheim CEDIA Digoxin Calibrators are substantiallyequivalent to the CEDIA Cardiac TDM Multi-Calibrators. |
| The following table compares the CEDIA Digoxin Calibrators with thepredicate device, CEDIA Cardiac TDM Multi-Calibrators. Specific data onthe performance of the test have been incorporated into the draft labeling inattachment 5. Labeling for the predicate device in provided in attachment 6. |
Similarities:
- · Similar concentration of digoxin.
- Similar matrix Differences:
| Feature | CEDIA DigoxinCalibrators | CEDIA Cardiac TDMMulti-Cals |
|---|---|---|
| Configuration | sold with reagents in kit | sold separately fromreagents |
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Summary, Continued
Image /page/2/Picture/1 description: The image is a black and white logo. The logo is a black square with the words "mannheim" written vertically along the left side of the square. Inside the square is a white circle with the word "boehringer" written horizontally across the center of the circle.
- Comparison to predicate device, (cont.)
Performance Characteristics:
· Method Comparison: equivalent correlation between predicate device Multi-Calibrators and the CEDIA Digoxin Calibrators.
• Stability: equivalent open vial and shelf-life stability performance to the predicate device.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles, suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the figure, emphasizing the department's role within the United States. The logo is presented in black and white, giving it a clean and official appearance.
JUL 2 4 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Yvette R. Lloyd Regulatory Affairs Specialist Boehringer Mannheim Corporation 2400 Bisso Lane P.O. Box 4117 Concord, California 94524-4117
K972433 Re : CEDIA Digoxin Calibrators II Requlatory Class: Product Code: DLJ Dated: June 26, 1997 Received: June 30, 1997
Dear Ms. Lloyd:
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 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 requirement, 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 Requlations.
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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 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
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510(k) Number (if known): N/A
Device Name: CEDIA® Digoxin Calibrators.
Indications For Use:
ික්ක මෙම විද්යාලී
ের পরি
:
The CEDIA Digoxin Calibrators are used to calibrate the CEDIA Digoxin II assay on the Synchron.
The CEDIA Digoxin Calibrators are used to determine drug concentrations.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number - 1972433
§ 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.