(15 days)
Not Found
Not Found
No
The description focuses on chemical components and calibration verification, with no mention of AI or ML technologies.
No
The device is described as a calibration verification solution for an assay, used to verify the calibration assignment of a diagnostic test. It is not used to treat, diagnose, cure, or prevent disease.
No
Explanation: This device is a calibration verification solution used to ensure an assay is calibrated correctly; it does not directly diagnose a patient's condition.
No
The device description explicitly states it is manufactured using physical components like human serum albumin, CA 125, stabilizers, and preservatives, indicating it is a physical reagent, not software.
Based on the provided information, the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it is used to "verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CA 125II assay." This is a function performed in vitro (outside the body) on a sample (presumably a control solution) to ensure the accuracy of a diagnostic test.
- Device Description: The description mentions it is manufactured using human serum albumin, CA 125, stabilizers, and preservatives, and the analyte is spiked into a matrix. This describes a reagent or control material used in a laboratory setting.
- Purpose: The purpose is to verify the calibration of an assay (the Elecsys® CA 125II assay), which is itself an IVD used to measure CA 125 levels in patient samples. Calibration verification is a critical step in ensuring the reliability of an IVD test result.
- Predicate Device: The mention of a predicate device, "Elecsys® CalCheck™ TSH," further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
Therefore, the Elecsys® CalCheck™ CA 125II fits the definition of an In Vitro Diagnostic device because it is a reagent/control used in vitro to verify the performance of another diagnostic assay.
N/A
Intended Use / Indications for Use
The Roche Diagnostics/Boehringer Mannheim CorporationElecsys® CalCheck™ CA 125II is used to verify the calibration assignment for the Roche Diagnostics/Boehringer Mannheim CorporationElecsys CA 125II assay. Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II 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™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck CA 125II is manufactured using human serum albumin, CA 125, stabilizers, and preservatives. The analyte is appropriately spiked into the calcheck matrix to the correct calcheck concentration levels. The calcheck are in process checked and quality controlled against ID-GC/MS.
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)
The Elecsys® CalCheck™ CA 125II was evaluated for value assignment and stability.
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.
Not Found
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
§ 862.1660 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.
0
APR 23 1998
1
,
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 | Roche Diagnostics/Boehringer Mannheim Corporation
4300 Hacienda Drive
Pleasanton, CA 94566-0900
(925) 730 - 8215
Fax number: (925) 225 - 0654 |
| | Contact Person: Patricia M. Klimley |
| | Date Prepared: April 7, 1998 |
| 2.
Device Name | Proprietary name: Elecsys® CalCheck™ CA 125II
Common name: Calibration Verification Material
Classification name: Single (specified) analyte controls (assayed + unassayed) |
| 3.
Predicate
device | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys®
CalCheck™ CA 125II is substantially equivalent to the currently marketed
Elecsys® CalCheck™ TSH. |
| 4.
Device
Description | The Roche Diagnostics/Boehringer Mannheim Corporation Elecsys CalCheck
CA 125II is manufactured using human serum albumin, CA 125, stabilizers,
and preservatives. The analyte is appropriately spiked into the calcheck
matrix to the correct calcheck concentration levels. The calcheck are in
process checked and quality controlled against ID-GC/MS. |
| 5.
Intended use | The Roche Diagnostics/Boehringer Mannheim CorporationElecsys®
CalCheck™
CA 125II is used to verify the calibration assignment for the
Roche Diagnostics/Boehringer Mannheim CorporationElecsys CA 125II
assay. |
| 6.
Comparison
to predicate
device | The Roche Diagnostics/Boehringer Mannheim CorporationElecsys®
CalCheck™ CA 125II is substantially euivalent to other products in
commercial distribution intended for similar use. Most notably, it is
substantially equivalent to the currently marketed Elecsys® CalCheck™
TSH. |
| | Both products are intended to be used for the verification of calibration for
analytes on automated immunoassay analyzers. |
| 7. Performance
Characteristics | The Elecsys® CalCheck™ CA 125II was evaluated for value assignment and
stability. |
Continued on next page
11981278
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510(k) Summary, Continued
HalleGolo "Goger "no"
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 3 1998
Patricia M. Klimley Manager, Elecsys Regulatory Affairs Roche Diaqnostics/Boehringer Manneim Corporation 4300 Hacienda Drive P.O. Box 9002 Pleasanton, California 94566-0900
Re : K981278 Elecsys® CalCheck™ CA 125II Requlatory Class: I Product Code: JJX Dated: April 7, 1998 Received: April 8, 1998
Dear Ms. Klimley:
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 qeneral 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. ನ್ನ 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 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 Bitman
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):
Device Name: Roche Diagnostics/Boehringer Mannheim Corporation Elecsys® CalCheck™ CA 125II
Indications For Use:
Elecsys® CalCheck™ CA 125II calibration verification solutions comprise three levels - low, mid, and high - each with a defined CA 125II 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™ CA 125II is intended for use in periodic verification of the calibration of the Elecsys® CA 125II assay. . . . . . . . . . . . . . . . . . . . . . . . .
(Division Sign-off)
Division of Clinical Cancer vices
510(k) Number k98 298
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| 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) |
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