(98 days)
Not Found
No
The summary describes a control product for an immunoassay, with no mention of AI or ML in its function or development.
No
The device is an assayed control for calibration verification and assay range verification for in vitro diagnostic use, not for treating patients.
No
The device is described as an "assayed control" used for "calibration verification" and "verification of the assay range" of another reagent. This indicates it is used to ensure the accuracy and proper functioning of a diagnostic test, rather than directly performing a diagnosis itself.
No
The device description clearly states it is a lyophilized product consisting of equine and human serum, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The very first sentence explicitly states "for in vitro diagnostic use only."
- Device Description: The description details a product used in a laboratory setting (lyophilized product, serum matrix, analyte spiking) for testing purposes.
- Predicate Device(s): The listed predicate devices are also IVDs (Elecsys C-Peptide CalCheck 5 and Elecsys CA 125 II CalCheck).
The purpose of this device is to verify the calibration and assay range of an IVD reagent (Elecsys CA 125 II reagent) on IVD analyzers (Elecsys and cobas e immunoassay analyzers). This function is inherently part of the in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The Elecsys CA 125 II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
Product codes
JJX
Device Description
The Elecsys CA 125 II CalCheck 5 is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2-5. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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 Roche Diagnostics name, address, 9115 Hague Road, P.O. Box 50416 contact Indianapolis, IN 46250-0416 317-521-3501 Contact Person: Kelly French Phone: 317-521-3208 Fax: 317-521-2324 Email: kelly.french@roche.com Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com Date Prepared: June 30, 2010 Device Name Proprietary name: Elecsys CA 125 II CalCheck 5 Common name: CA 125 II CalCheck 5 Classification name: Single (specified) analyte controls (assayed and unassayed) Predicate The Elecsys CA 125 II CalCheck 5 is substantially equivalent to other device products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys C-Peptide CalCheck 5 (K100810) and the Elecsys CA 125 II CalCheck (K003967). Device The Elecsys CA 125 II CalCheck 5 is a lyophilized product consisting of Description · equine serum in level 1 and human serum matrix for levels 2-5. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. Intended use The Elecsys CA 125 CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
510(k) Summary
NOV - 1 2010
1
Comparison Table The table below compares Elecsys CA 125 CalCheck 5 with the predicate devices, Elecsys C-Peptide CalCheck 5 (K100810) and the CA 125 II CalCheck (K003967).
Please note that the use of two predicates has been utilized for this submission based on previous FDA feedback to several of the most recently FDA-cleared CalCheck 5 products. The first predicate shows that the CA 125 II CalCheck 5 is substantially equivalent to another CalCheck 5 product. The Elecsys CA 125 II CalCheck 5 is also substantially equivalent to the second predicate, CA 125 II CalCheck, with several key similarities, especially the analyte. The shaded fields indicate similar characteristics between the candidate device and a predicate device.
| Characteristic | Elecsys C-Peptide
CalCheck 5 (K100810) | Elecsys CA 125 II CalCheck
5
(Candidate Device) | Elecsys CA 125 II CalCheck
(K003967) |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys C-Peptide CalCheck
5 is an assayed control for use in
calibration verification and for
use in the verification of the
serum and plasma assay range
established by the Elecsys
C-Peptide reagent on the.
indicated Elecsys and cobas e
immunoassay analyzers. | The Elecsys CA 125 II Calcheck
5 is an assayed control for use in
calibration verification and for
use in the verification of the
assay range established by the
Elecsys CA 125 II reagent on the
indicated Elecsys and cobas e
immunoassay analyzers, for in
vitro diagnostic use only. | For use in verification of the
calibration established by the
Elecsys CA 125 II reagent on the
Elecsys 2010 and 1010
Immunoassay analyzers. |
| Analyte | C-Peptide | CA 125 | CA 125 |
| Levels | Five | Five | Three |
| Format | Lyophilized | Same | Same |
| Handling | Reconstitute Check 1, Check 2,
Check 3, Check 4, and Check 5
with exactly 1.0 mL distilled or
deionized water. Allow to stand
closed for 15 minutes, then mix
gently by inversion. | Reconstitute Check 1, Check 2,
Check 3, Check 4, and Check 5
with exactly 1.0 mL distilled or
deionized water. Allow to stand
closed for 15 minutes, then mix
gently by inversion. | Reconstitute Check 1, Check 2,
and Check 3 with exactly 1.0 mL
distilled or deionized water.
Allow to stand closed for 15
minutes, then mix gently by
inversion. |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20-25°C: 4 hours | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20-25°C: 4 hours | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20-25°C: 4 hours |
| Matrix | Equine serum matrix | Level 1: Equine serum
Levels 2-5: Human serum matrix | Level 1: Equine serum
Levels 2 & 3: Human serum
matrix |
Performance Characteristics
The Elecsys CA 125 II CalCheck 5 was evaluated for value assignment and stability.
: ..............................................................................................................................................................................
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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 consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the eagle. The text is in all caps and is relatively small compared to the eagle symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Roche Diagnostics c/o Ms. Kelly French Regulatory Affairs Consultant Roche Professional Diagnostics 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0416
NOV 0 1 2010
Re: K102086
Trade/Device Name: Elecsys CA 125II CalCheck 5 Regulation Number: 21CFR 8862.1660 Regulation Name: Quality control material, assayed and unassayed Regulatory Class: Class I (Reserved) Product Code: JJX Dated: October 8, 2010 Received: October 12, 2010
Dear Ms. French:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 net mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must
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Page 2 – Ms Kelly French
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/medicaldevices/resourcesforindustry/default.htm
Sincerely yours,
Tharai Im Chen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
K102086 510(k) Number (if known):
NOV 0 1 2010
Device Name: Elecsys CA 125 II CalCheck 5
Indication For Use:
The Elecsys CA 125 II CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys CA 125 II reagent on the indicated Elecsys and cobas e immunoassay analyzers, for in vitro diagnostic use only.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use __ i (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Bema Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102086
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