(15 days)
Not Found
No
The document describes a calibration verification solution for an assay, which is a chemical reagent used to check the accuracy of a diagnostic test. There is no mention of any computational or algorithmic processes that would suggest the use of AI or ML. The description focuses on the chemical composition and intended use for calibration verification.
No
The device is a calibration verification solution used to verify the calibration of an assay, not for treating any medical condition.
No.
The device is described as a "calibration verification solution" used to verify the calibration of an assay, not to diagnose a patient's condition.
No
The device description explicitly states it is a set of "stable liquid, bovine based materials," indicating it is a physical product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used to "verify the calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay." This assay is used to measure DIGOXIN levels, which is a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is described as "stable liquid, bovine based materials" with "defined DIGOXIN concentration." These are materials used to assess the performance of a diagnostic assay.
- Function: The device is used to "verify the calibration of the Elecsys® DIGOXIN reagent." Calibration verification is a crucial step in ensuring the accuracy and reliability of an in vitro diagnostic test.
- Predicate Device: The predicate device listed (K963147; Elecsys® CalCheck™ TSH) is also a calibration verification material for an Elecsys assay, further indicating that this type of product falls under the IVD category.
In summary, the device is a reagent used to ensure the proper functioning and accuracy of an in vitro diagnostic test (the Elecsys DIGOXIN assay), making it an IVD itself.
N/A
Intended Use / Indications for Use
The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify the calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay.
Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.
Product codes (comma separated list FDA assigned to the subject device)
DMP
Device Description
The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
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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.
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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§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.
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NOV 트'4 1997
11-11-173
、
| 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 - 8415
Fax number: (510) 225 - 0654 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Jody J. Savage
Date Prepared: October 17, 1997 |
| 2. Device Name | Proprietary name: Elecsys® CalCheck™ DIGOXIN
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3. Predicate device | The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH (K963147). |
| 4. Device Description | The Elecsys® CalCheck™ DIGOXIN is a three level single analyte set of stable liquid, bovine based materials. They are assayed in triplicate and the results compared to the target values. |
Continued on next page
1
510(k) Summary, Continued
| 5.
Intended use | The Boehringer Mannheim Elecsys CalCheck DIGOXIN is used to verify the
calibration assignment for the Boehringer Mannheim Elecsys DIGOXIN assay. |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6.
Comparison to
predicate device | The Elecsys® CalCheck™ DIGOXIN is substantially equivalent to the
currently marketed Elecsys® CalCheck™ TSH (K963147).
The following table compares the Elecsys® CalCheck™ DIGOXIN with the
predicate devices, Elecsys® CalCheck™ TSH. Specific data on the
performance of the test have been incorporated into the draft labeling in
attachment 5. Labeling for the predicate devices is provided in attachment 6. |
| | Similarities: |
| | • Configuration: Three CalCheck levels: low, mid, and high |
| | • Intended use: To verify calibration |
| | Differences: |
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and the first of the first of the state of the state of the state of the state of the states and the states of the states of the states and
| Feature | CalCheck DIGOXIN | CalCheck TSH |
|---|---|---|
| Matrix type | Bovine serum | Horse serum |
| Analyte | DIGOXIN | TSH |
Continued on next page
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure with outstretched arms, overlaid with three horizontal lines that suggest movement or energy. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the figure, indicating the organization's name and country.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Jody J. Savage .Consultant, Regulatory Affairs Boehringer Mannheim 4300 Hacienda Drive 94588-2722 Pleasanton, California
NOV - 4 1997
Re : K973973 Elecsys® CalCheck™ DIGOXIN Requlatory Class: I Product Code: DMP October 17, 1997 Dated: Received: October 20, 1997
Dear Ms. Savage:
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. ਉ 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 requlations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (chin oo), chip device maj uquifical 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 asborized in 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 Litman
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
4
510(k) Number (if known): N/A
Device Name: Elecsys® CalCheck™ DIGOXIN
Indications For Use:
Elecsys® CalCheck™ DIGOXIN calibration verification solutions comprise three levels - low, mid, and high - each with a defined DIGOXIN concentration. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® CalCheck™ DIGOXIN is intended for use in periodic verification of the calibration of the Elecsys® DIGOXIN reagent.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K973973 |
|---|---|
| --------------- | --------- |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
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