(24 days)
Not Found
No
The summary describes a set of chemical calibrators for an assay, with no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
No.
The device is a calibrator used to determine drug concentrations in an assay, not for treating or diagnosing a condition.
No
This device, the CEDIA Digoxin Calibrators, is used to calibrate an assay (CEDIA Digoxin II assay) that determines drug concentrations. Calibrators are reference materials used to ensure the accuracy of a diagnostic test; they are not diagnostic devices themselves that directly diagnose a condition or disease in a patient.
No
The device description clearly states it is a physical product (calibrators) manufactured using bovine serum albumin, digoxin, stabilizers, and preservatives. 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 used to calibrate an assay (CEDIA Digoxin II assay) to determine drug concentrations. This is a classic function of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition.
- Device Description: The description mentions the composition of the calibrators (bovine serum albumin, digoxin, stabilizers, and preservatives) and how they are used to calibrate an assay. This aligns with the nature of reagents and calibrators used in laboratory testing.
- Performance Studies: The summary of performance studies mentions "Method Comparison" and "Stability," which are typical studies conducted for IVD devices to demonstrate their performance and equivalence to predicate devices.
- Predicate Device: The mention of a predicate device (K962269; CEDIA Cardiac TDM Multi-Calibrators) further confirms that this device falls under the regulatory framework for IVDs, as predicate devices are used for comparison in the 510(k) submission process for new IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the intended use, device description, and regulatory context (predicate device) strongly indicate that this device is an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DLJ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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
| 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.
Submitter
name,
address,
contact | Boehringer Mannheim Corporation
2400 Bisso Lane
Concord, CA 94524-4117
(510) 674-0690 extension 8413
Fax number: (510) 687-1850
Contact Person: Yvette Lloyd
Date Prepared: June 27, 1997 |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2.
Device name | Proprietary name: CEDIA Digoxin Calibrators
Common name: Therapeutic drug monitoring calibrators for use in the calibration of the CEDIA Digoxin II assay.
Classification name: Calibrators, drug mixture |
| 3.
Predicate
device | The Boehringer Mannheim CEDIA Digoxin Calibrators are substantially equivalent to the CEDIA Cardiac TDM Multi-Calibrators (K962269). |
| 4.
Device
Description | 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. |
Continued on next page
1
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ﻤﺴﯿﺴﻪ
【 •
Continued on next page
1
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 II
assay on the Beckman Synchron. |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.
Comparison
to predicate
device | The Boehringer Mannheim CEDIA Digoxin Calibrators are substantially
equivalent to the CEDIA Cardiac TDM Multi-Calibrators. |
| | The following table compares the CEDIA Digoxin Calibrators with the
predicate device, CEDIA Cardiac TDM Multi-Calibrators. 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:
- · Similar concentration of digoxin.
- Similar matrix Differences:
| Feature | CEDIA Digoxin
Calibrators | CEDIA Cardiac TDM
Multi-Cals |
|---------------|------------------------------|----------------------------------|
| Configuration | sold with reagents in kit | sold separately from
reagents |
Continued on next page
2
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.
3
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.
4
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 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
5
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