(67 days)
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No
The document describes a control material for an immunoassay, not a device that processes data or images using AI/ML. There are no mentions of AI, ML, or related concepts.
No
Explanation: The device is described as an assayed control for calibration verification and assay range verification for in vitro diagnostic (IVD) tests, not a device used for treating disease or maintaining health.
No
Explanation: The device is described as an "assayed control" used for calibration verification and verification of assay range for a rubella IgG reagent. It is used to check the performance of a diagnostic assay, not to diagnose a disease directly.
No
The device description clearly states it is a lyophilized product consisting of human antibodies in a human serum matrix, indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys Rubella IgG CalCheck 5 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "calibration verification" and "verification of the assay range" for the Elecsys Rubella IgG reagent on specific immunoassay analyzers. This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: It's a "lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix." This is a reagent designed to interact with a sample (in this case, the Elecsys Rubella IgG reagent) to produce a result that helps evaluate the diagnostic test's accuracy.
- Predicate Device: The mention of a predicate device (K090311; Elecsys Rubella IgG CalCheck) which is also a CalCheck product, further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic Device," the intended use and nature of the product strongly align with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This product is used to ensure the accuracy of a diagnostic test for Rubella IgG.
N/A
Intended Use / Indications for Use
The Elecsys Rubella IgG 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 Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJX, LFX
Device Description
The Elecsys Rubella IgG CalCheck 5 is a lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
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 Rubella IgG CalCheck 5 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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OCT 3 0 2009
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. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3952 | |
| 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: August 21, 2009 | |
| Device Name | Proprietary name: Elecsys Rubella IgG CalCheck 5 |
| Common name: Rubella IgG CalCheck 5 | |
| Classification name: Single (specified) analyte controls (assayed and unassayed) | |
| Predicate device | The Elecsys Rubella IgG CalCheck 5 is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys Rubella IgG CalCheck (K090311). |
| Device Description | The Elecsys Rubella IgG CalCheck 5 is a lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. |
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Intended use The Elecsys Rubella IgG 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 Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
510(k) Summary, Continued
The table below compares Elecsys Rubella IgG CalCheck 5 with the Comparison Table predicate device, Elecsys Rubella IgG Calcheck (K090311).
| Characteristic | Elecsys Rubella IgG CalCheck
(K090311) | Elecsys Rubella IgG
CalCheck 5 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Elecsys Rubella IgG CalCheck
is an assayed calibrator control
intended for use in the verification
of the calibration established by the
Elecsys Rubella IgG reagent on the
Elecsys 2010, MODULAR
ANALYTICS E170 and cobas e
immunoassay analyzers. | The Elecsys Rubella IgG 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 Rubella
IgG reagent on the Elecsys 2010,
MODULAR ANALYTICS E170
and cobas e immunoassay
analyzers. |
| Levels | Three | Five |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mL
distilled or deionized water and
allow standing closed for 15
minutes, then mix gently by
inversion. | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Reconstituted:
• 20 – 25°C : 4 hrs | Same |
| Matrix | Human serum matrix | Same |
Performance Characteristics The Elecsys Rubella IgG CalCheck 5 was evaluated for value assignment and stability.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping lines, resembling a human figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
Kelly French Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN, 46250-3831
OCT 3 0 2009
K 092585 Re:
| Trade/Device Name: | Elecsys Rubella IgG CalCheck 5 |
|---|---|
| Regulation Number: | 21CFR §862.1660 |
| 21CFR §866.3510 | |
| Regulation Name: | Quality Control Material (assayed and unassayed) |
| Rubella Virus Serological Reagents | |
| Regulatory Class: | Class I (Quality Control) |
| Class II (Rubella IgG) | |
| Product Code: | JJX, LFX |
| Dated: | August 21, 2009 |
| Received: | August 24, 2009 |
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.
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not 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 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).
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,
Vaisattaygus
Sally A. Hojvat, M.Sc ., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
10.92585 510(k) Number (if known):
Device Name: Elecsys Rubella IgG CalCheck 5
Indication For Use:
The Elecsys Rubella IgG 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 Rubella IgG reagent on the Elecsys 2010, MODULAR ANALYTICS E170 and cobas e immunoassay analyzers.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (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)
Uve Schuf
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K092585
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