(256 days)
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No
The document describes a calibration check product for an immunoassay analyzer, which is a chemical reagent used to verify the accuracy of the analyzer's measurements. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the chemical composition and stability of the calibration material.
No
The device is a calibrator, used to verify the calibration of an immunoassay reagent, not to directly treat a medical condition.
No
Explanation: The device is a calibrator for an immunoassay analyzer (Elecsys® proBNP reagent) and is used to verify the calibration of that analyzer, not to directly diagnose a patient's condition.
No
The device description clearly states it is a "lyophilized product manufactured using proBNP in human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys® proBNP CalCheck is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for "verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers." This indicates it's used in a laboratory setting to ensure the accuracy of a diagnostic test (the Elecsys® proBNP reagent).
- Device Description: It's a "lyophilized product manufactured using proBNP in human serum matrix." This describes a reagent or control material used in laboratory testing.
- Predicate Device: The mention of a predicate device (K001015; Elecsys® Thyroglobulin CalCheck) strongly suggests it's a regulated medical device, and the predicate device's name also indicates it's a calibration check product for an immunoassay, which is a common type of IVD.
Calibration checks are essential components of the quality control process for many IVD tests, ensuring the reliability of the results. Therefore, a device specifically designed for this purpose within the context of an immunoassay analyzer falls under the definition of an IVD.
N/A
Intended Use / Indications for Use
The Elecsys® proBNP CalCheck is intended for use in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys® proBNP CalCheck is a lyophilized product manufactured using proBNP in human serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels. Elecsys® proBNP CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined proBNP concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
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)
The Elecsys® proBNP CalCheck was evaluated for value assignment and stability.
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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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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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510(k) Summary
NOV 2 9 2002
| 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. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Road Indianapolis, IN 46250 521 - 3831 |
| Contact Person: Sherri L Coenen | |
| Date Prepared: March 15, 2002 | |
| Device Name | Proprietary name: Elecsys® proBNP CalCheck |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + unassayed) | |
| Predicate device | The Elecsys® proBNP CalCheck is substantially equivalent to the currently marketed Elecsys® Thyroglobulin CalCheck (K001015). |
| Device Description | The Elecsys® proBNP CalCheck is a lyophilized product manufactured using proBNP in human serum matrix. The analyte is appropriately spiked into the CalCheck matrix to the correct concentration levels. |
1
510(k) Summary, Continued
:
| Intended use | The Elecsys® proBNP CalCheck is used in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers. |
|---|---|
| Comparison to predicate device | The Elecsys® proBNP CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® Thyroglobulin CalCheck (K001015). |
| Performance Characteristics | The Elecsys® proBNP CalCheck was evaluated for value assignment and stability. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 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 head. 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
Ms. Kay A. Taylor Regulatory Program Principal Centralized Diagnostic Submissions Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
NOV 2 9 2002
Re: K020883 Trade/Device Name: Elecsys® proBNP CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: November 20. 2002 Received: November 22, 2002
Dear Ms. Taylor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that vour device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
.
510(k) Number (if known): N/A
Device Name: Elecsys® proBNP CalCheck
Indications For Use:
.
Elecsys® proBNP CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined proBNP concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at a clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® proBNP CalCheck is intended for use in the verification of the calibration established by the Elecsys® proBNP reagent on Elecsys® 1010/2010/MODULAR ANALYTICS E170 immunoassay analyzers.
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_ (