(88 days)
Not Found
No
The document describes a calibrator control for an immunoassay analyzer, which is a standard laboratory product. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is described as an "assayed calibrator control" used for verification of calibration of a reagent on immunoassay analyzers. It is a control product for laboratory use rather than a device for treating patients.
No.
The device is described as an "assayed calibrator control" used for the "verification of the calibration" of other diagnostic reagents/analyzers. It does not directly diagnose a condition but rather ensures the accuracy of devices that perform diagnoses.
No
The device description explicitly states it is a "lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix," indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys Rubella IgG CalCheck is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "verification of the calibration established by the Elecsys Rubella IgG reagent on the Elecsys 2010, the MODULAR ANALYTICS E170, and cobas e immunoassay analyzers." This indicates it's used in a laboratory setting to ensure the accuracy of a diagnostic test (the Elecsys Rubella IgG reagent).
- Device Description: It's a "lyophilized product consisting of human anti-Rubella IgG antibodies in human serum matrix." This describes a biological material used in a laboratory test.
- Predicate Device: The mention of a predicate device (K040157; Elecsys C-Peptide CalCheck) which is also a "CalCheck" product, strongly suggests this device falls under the same regulatory category, which for these types of products is IVD.
IVD devices are used to examine specimens from the human body (like blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease. While this specific device isn't directly diagnosing a patient, it's an essential component used with a diagnostic test to ensure its reliability, making it an IVD accessory or calibrator.
N/A
Intended Use / Indications for 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, the 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 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
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 Rubella IgG CalCheck 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.
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
510(k) Summary
MAY - 5 2009
| Introduction | According to the requirements of 21 CFR 807.92, the following
information provides details to understand the basis for a
determination of substantial equivalence. |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name, address, contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
317-521-3208
Contact Person: Kelly French
Date Prepared: February 2, 2009 |
| Device Name | Proprietary name: Elecsys Rubella IgG CalCheck
Common name: Rubella IgG CalCheck
Classification name: Single (specified) analyte controls (assayed and
unassayed) |
| Device Description | The Elecsys Rubella IgG CalCheck 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. |
| 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, the
MODULAR ANALYTICS E170, and cobas e immunoassay
analyzers. |
| Comparison Table | The table below compares Elecsys Rubella IgG CalCheck with the
predicate device, Elecsys C-Peptide Calcheck (K040157). |
| Characteristic | Elecsys C-Peptide CalCheck
(K040157) | Elecsys Rubella IgG
CalCheck |
|----------------|-----------------------------------------|---------------------------------------------------------------|
| Intended Use | For use in the verification of the | For use in the verification of
the calibration established |
1
| Characteristic | Elecsys C-Peptide CalCheck
(K040157) | Elecsys Rubella IgG
CalCheck |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | calibration established by the Elecsys
C-Peptide reagent on the Elecsys and
cobas e immunoassay analyzers. | by the Elecsys Rubella IgG
reagent on the Elecsys
2010, the MODULAR
ANALYTICS E170, and
cobas e immunoassay
analyzers. |
| Levels | Three | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute with exactly 1.0 mL
distilled or deionized water and allow
standing closed for 15 minutes, then
mix gently. | Same |
| Stability | Unopened:
Store at 2-8°C until expiration date
Reconstituted:
20 - 25°C: 4 hrs | Same |
| Matrix | Equine serum matrix | Human Serum |
Performance Characteristics
.
:
The Elecsys Rubella IgG CalCheck was evaluated for value assignment and stability.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings forming three distinct, curved shapes.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kelly French Regulatory Affairs Consultant Roche Diagnostics Roche Professional Diagnostics 9115 Haguc Road PO Box 50416 Indianapolis, IN, 46250-3831
| : | K090311 |
|---|---|
| Trade/Device Name: | Elecsys Rubella IgG CalCheck |
| Regulation Number: | 21CFR §866.1660 |
| 21CFR §866.3510 | |
| Regulation Name: | Quality control material (assayed and unassayed) |
| Rubella virus serological reagents | |
| Regulatory Class: | Class I reserved (quality control) |
| Class II (Rubella IgG) | |
| Product Code: | JJX |
| LFX | |
| Dated: | February 5, 2009 |
| Received: | February 6, 2009 |
MAY - 5 2009
Dear Ms. French:
Re:
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 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
3
Page 2 -
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 ' (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attgins
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
4
Indication for Use
510(k) Number (if known): K090311
Device Name:
Elecsys Rubella İgG CalCheck
Indication For 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.
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)
Uwe Schef
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
2090311 510(k)