(91 days)
Not Found
No
The summary describes a quality control product for immunoassays, with no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: This device is a quality control product for immunoassays, not a device used for treating or diagnosing a medical condition in a patient.
No
The device is described as a quality control product for immunoassays, not a device used to diagnose a condition in a patient.
No
The device description explicitly states it is a "lyophilized product consisting of antibodies in a human serum matrix," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and cobas e immunoassay analyzers." Immunoassays are in vitro diagnostic tests.
- Device Description: The description mentions it's a "lyophilized product consisting of antibodies in a human serum matrix." This is a common format for controls used in in vitro diagnostic testing.
- Anatomical Site: It's listed as "Not Applicable (In vitro diagnostic)," which further confirms its nature as a test performed outside the body.
- Predicate Device: The presence of a predicate device with a K number (K080092) indicates it has gone through a regulatory process for medical devices, specifically IVDs in this context.
Therefore, based on the provided information, the Elecsys PreciControl ThyroAB is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
The Elecsys PreciControl ThyroAB is a lyophilized product consisting of antibodies in a human serum matrix. During manufacture, the antibodies are 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 PreciControl ThyroAB was evaluated for value assignment, stability, and duration of reconstitution.
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—Elecsys PreciControl ThyroAB
. ·
NOV - 3 2009
| Introduction | In accordance with 21`CFR 807.92, Roche Diagnostics hereby submits
official notification as required by Section 510(k) of the Federal Food, Drug
and Cosmetics Act of our intention to market the device described in this
Premarket Notification [510(k)]. |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
Name, Address,
Contact | Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250 |
| | Contact Person: Sarah Baumann
Phone: 317-521-3952
Fax: 317-521-2324
Email: sarah.baumann@roche.com |
| | Secondary Contact: Stephanie Greeman
Phone: 317-521-2458
Fax: 317-521-2324
Email: stephanie.greeman@roche.com
Date Prepared: July 30, 2009 |
| Submission
Purpose | PreciControl ThyroAB is used for quality control of specified Elecsys
immunoassays on the Elecsys and cobas e immunoassay analyzers. This
product contains control material for numerous Elecsys assays in one
convenient solution. |
| | Changes to PreciControl ThyroAB consist of the addition of
anti-thyroperoxidase (Anti-TPO) and anti-thyroglobulin (Anti-TG) antibodies
to extend the current functionality. |
| Device Name | Proprietary name: Elecsys PreciControl ThyroAB
Common name: PreciControl ThyroAB
Classification name: Multi-Analyte Controls, All Kinds (assayed and
Unassayed) |
| | Continued on next page |
Page 1 of 4
:
1
510(k) Summary—Elecsys PreciControl ThyroAB, Continued
| Device
Description | The Elecsys PreciControl ThyroAB is a lyophilized product consisting of
antibodies in a human serum matrix. During manufacture, the antibodies are
spiked into the matrix at the desired concentration levels. | | |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Intended Use | Elecsys PreciControl ThyroAB is used for quality control of the Elecsys
Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys and
cobas e immunoassay analyzers. | | |
| Predicate
Device | The modified Elecsys PreciControl ThyroAB is substantially equivalent to
other products in commercial distribution intended for similar use. We claim
equivalency to the currently marketed Elecsys PreciControl ThyroAB
(K080092). | | |
| Device
Comparison—
Similarities | The table below presents the similarities between the modified Elecsys
PreciControl ThyroAB and the predicate device, Elecsys PreciControl
ThyroAB (K080092). | | |
| | Characteristic | Predicate Device
Elecsys PreciControl
ThyroAB
(K080092) | Elecsys PreciControl
ThyroAB |
| Characteristic | Predicate Device
Elecsys PreciControl
ThyroAB
(K080092) | Elecsys PreciControl
ThyroAB | |
| Intended use | Elecsys PreciControl
ThyroAB is used for
quality control of the
Elecsys Anti-TSHR
immunoassay on the
Elecsys and cobas e
immunoassay analyzers. | Elecsys PreciControl
ThyroAB is used for
quality control of the
Elecsys Anti-TSHR, Anti-TPO and Anti-Tg
immunoassays on the
Elecsys and cobas e
immunoassay analyzers. | |
| | | | |
| Analyte
concentration | Anti-TSHR (IU/L):
Level 1 = 4
Level 2 = 16 | Anti-TSHR (IU/L):
Level 1 = 4
Level 2 = 16
Anti-TPO (IU/mL):
Level 1 = 35
Level 2 = 100
Anti-TG (IU/mL):
Level 1 = 100
Level 2 = 200 | |
| Antibody source
and type | Anti-TSHR: Human
monoclonal | Anti-TSHR: Human
monoclonal
Anti-TPO: Sheep
polyclonal
Anti-TG: Sheep
polyclonal | |
| Handling | Dissolve carefully the
contents of one bottle by
adding exactly 2.0 mL of
distilled water and allow
to stand closed for 15
minutes to reconstitute.
Mix carefully, avoiding
the formation of foam. | Dissolve carefully the
contents of one bottle by
adding exactly 2.0 mL of
distilled or deionized
water and allow to stand
closed for 30 minutes to
reconstitute. Mix
carefully, avoiding the
formation of foam. | |
Elecsys and cobas e
-Elecsys 2010 -MODULAR ANALYTICS E170
-cobas e 411 -cobas e 601 Lyophilized
Human Serum
immunoassay analyzers:
Analyzer System
Format Matrix
Continued on next page
Same
Same
Same
2
510(k) Summary—Elecsys PreciControl ThyroAB, Continued
Device Comparison-Differences
The table below presents the differences between the modified Elecsys PreciControl ThyroAB and the predicate device, Elecsys PreciControl ThyroAB (K080092).
Continued on next page
CONFIDENTIAL
3
510(k) Summary-Elecsys PreciControl ThyroAB, Continued
| Device
Comparison—
Differences
(continued) | The table below presents the differences between the modified Elecsys
PreciControl ThyroAB and the predicate device, Elecsys PreciControl
ThyroAB (K080092). |
| ----------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Characteristic | Predicate Device
Elecsys PreciControl
ThyroAB
(K080092) | Elecsys PreciControl
ThyroAB |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stability | Unopened:
Store at 2-8°C until expiration
date | Unopened:
Store at 2-8°C until expiration
date |
| | Reconstituted:
on the analyzer at 20-25°C:
up to 3 hrs
at -20°C: 3 months (freeze
only once)
After Thawing:
use only once. | Reconstituted:
on the analyzer at 20-25 °C:
up to 5 hrs
at -20°C: 1 month (freeze
only once)
or at 2-8°C for 3 day
(for Anti-TG & Anti-TPO
only) |
Performance Characteristics
The Elecsys PreciControl ThyroAB was evaluated for value assignment, stability, and duration of reconstitution.
4
Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Roche Diagnostics c/o Ms. Sarah Baumann Regulatory Affairs Cousultant 9115 Hague Road, PO Box 50410 ~ Indianapolis, Indiana 46250-4016
NOV - 3 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Re: K092320
Trade Name: Elecsys PreciControl-ThyroAB Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material (assayed and unassayed). Regulatory Class: Class I, reserved Product Codes: JJY Dated: September 30, 2009 Received: October 01, 2009
Dear Ms. Baumann:
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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
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 (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 796-5760. 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/ReportaProblem/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Ko92320
Device Name: Elecsys PreciControl ThyroAB
Indication For Use:
Elecsys PreciControl ThyroAB is used for quality control of the Elecsys Anti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys 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)
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
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