(91 days)
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.
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.
Here's an analysis of the provided text regarding the Elecsys PreciControl ThyroAB, focusing on acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary for a quality control device. These types of submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than presenting extensive clinical efficacy studies typical of diagnostic or therapeutic devices. Therefore, the details requested in your prompt regarding patient data, experts, and human reader studies are generally not applicable to this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material like Elecsys PreciControl ThyroAB, the "performance" primarily relates to its characteristics as a control, such as stability and its ability to provide target values for the assays it controls. The acceptance criteria are essentially what Roche Diagnostics established for the modified product to be considered equivalent and suitable for its expanded intended use.
| Acceptance Criteria Category | Specific Criteria/Reported Performance | Notes on Acceptance (Based on Document) |
|---|---|---|
| Intended Use | Expanded to include Elecsys Anti-TPO and Anti-Tg immunoassays. | Met. The submission details the addition of Anti-TPO and Anti-Tg antibodies to extend current functionality. |
| Analyte Concentration | Specific concentration levels for Anti-TSHR, Anti-TPO, and Anti-Tg. | Met. The submission lists the target concentrations for each analyte at two levels. |
| Antibody Source and Type | Anti-TSHR: Human monoclonal; Anti-TPO: Sheep polyclonal; Anti-TG: Sheep polyclonal. | Met. The submission details the antibody sources and types for each analyte. |
| Handling (Reconstitution) | Dissolve contents with 2.0 mL distilled/deionized water, stand for 30 minutes, mix carefully. | Met. This is a specific instruction provided for the modified device. |
| Stability (Unopened) | Store at 2-8°C until expiration date. | Met. No change from predicate, implying continued acceptance. |
| Stability (Reconstituted on Analyzer) | Up to 5 hours at 20-25°C. | Met. Improved from predicate (previously 3 hours). This is a positive change, suggesting acceptance. |
| Stability (Reconstituted frozen) | At -20°C: 1 month (freeze only once). | Met. Decreased from predicate (previously 3 months), but still an accepted stability specification for the modified product. |
| Stability (Reconstituted refrigerated for Anti-TG & Anti-TPO only) | At 2-8°C for 3 days. | Met. This is a new stability specification for the added analytes, implying acceptance for their specific handling. |
| Performance Characteristics | Evaluation for value assignment, stability, and duration of reconstitution. | Met. The document states these evaluations were performed, implying they demonstrated satisfactory results for the product's function as a control. The specific quantitative results are not provided in this summary but would have been part of the full submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in this 510(k) summary. For a quality control material, the "test set" would typically refer to the various batches of the control material manufactured and tested during the validation process. The number of individual measurements or experiments performed on these batches would constitute the sample size. However, the summary does not provide these numbers.
- Data Provenance: Not specified. Given that Roche Diagnostics is a global company, the studies could have been conducted at various internal facilities. The summary does not indicate retrospective or prospective and is not typically relevant for a quality control material validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device. "Ground truth" in the context of a diagnostic device often refers to clinical diagnoses established by expert clinicians (e.g., radiologists, pathologists). For a quality control material, the "ground truth" or reference values are established through rigorous analytical testing using reference methods and certified reference materials, typically performed by laboratory scientists and statisticians at the manufacturer's facility, not clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies among multiple human readers or interpreters of clinical data for diagnostic devices. For a quality control material, analytical results are compared to predefined analytical specifications or reference values, not adjudicated clinical interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not applicable to this type of device. MRMC studies are used to evaluate the performance of diagnostic imaging devices (often AI-assisted) by assessing how human readers' performance changes with or without the device. As Elecsys PreciControl ThyroAB is a quality control material for immunoassays, such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable to this type of device. "Standalone" performance generally refers to the accuracy of an AI algorithm in performing a diagnostic task without human intervention. This device is a control material used to monitor the performance of immunoassays, not an AI algorithm itself.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" (or more appropriately, the assigned values or reference values) for the analytes (Anti-TSHR, Anti-TPO, Anti-Tg) are established through:
- Reference Methods and Materials: The concentrations of the antibodies (Anti-TSHR, Anti-TPO, Anti-Tg) are "spiked into the matrix at the desired concentration levels" during manufacture. The accuracy of these concentrations and their stability are verified using highly accurate, traceable reference methods and often against international reference preparations or certified reference materials, where available.
- Value Assignment Studies: These studies involve multiple measurements across different instruments and laboratories to assign a consensus target value and acceptable range for each analyte in the control material.
The text explicitly mentions "The Elecsys PreciControl ThyroAB was evaluated for value assignment, stability, and duration of reconstitution," which confirms these types of analytical ground truth establishment processes were followed.
8. The Sample Size for the Training Set
This information is not applicable to this type of device. The concept of a "training set" applies to machine learning algorithms. Elecsys PreciControl ThyroAB is a physical chemical control material, not an AI algorithm, and therefore does not have a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
{0}------------------------------------------------
510(k) Summary—Elecsys PreciControl ThyroAB
. ·
NOV - 3 2009
| Introduction | In accordance with 21`CFR 807.92, Roche Diagnostics hereby submitsofficial notification as required by Section 510(k) of the Federal Food, Drugand Cosmetics Act of our intention to market the device described in thisPremarket Notification [510(k)]. |
|---|---|
| SubmitterName, Address,Contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250 |
| Contact Person: Sarah BaumannPhone: 317-521-3952Fax: 317-521-2324Email: sarah.baumann@roche.com | |
| Secondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.comDate Prepared: July 30, 2009 | |
| SubmissionPurpose | PreciControl ThyroAB is used for quality control of specified Elecsysimmunoassays on the Elecsys and cobas e immunoassay analyzers. Thisproduct contains control material for numerous Elecsys assays in oneconvenient solution. |
| Changes to PreciControl ThyroAB consist of the addition ofanti-thyroperoxidase (Anti-TPO) and anti-thyroglobulin (Anti-TG) antibodiesto extend the current functionality. | |
| Device Name | Proprietary name: Elecsys PreciControl ThyroABCommon name: PreciControl ThyroABClassification name: Multi-Analyte Controls, All Kinds (assayed andUnassayed) |
| Continued on next page |
Page 1 of 4
:
{1}------------------------------------------------
510(k) Summary—Elecsys PreciControl ThyroAB, Continued
| DeviceDescription | The Elecsys PreciControl ThyroAB is a lyophilized product consisting ofantibodies in a human serum matrix. During manufacture, the antibodies arespiked into the matrix at the desired concentration levels. | ||
|---|---|---|---|
| Intended Use | Elecsys PreciControl ThyroAB is used for quality control of the ElecsysAnti-TSHR, Anti-TPO and Anti-Tg immunoassays on the Elecsys andcobas e immunoassay analyzers. | ||
| PredicateDevice | The modified Elecsys PreciControl ThyroAB is substantially equivalent toother products in commercial distribution intended for similar use. We claimequivalency to the currently marketed Elecsys PreciControl ThyroAB(K080092). | ||
| DeviceComparison—Similarities | The table below presents the similarities between the modified ElecsysPreciControl ThyroAB and the predicate device, Elecsys PreciControlThyroAB (K080092). | ||
| Characteristic | Predicate DeviceElecsys PreciControlThyroAB(K080092) | Elecsys PreciControlThyroAB | |
| Characteristic | Predicate DeviceElecsys PreciControlThyroAB(K080092) | Elecsys PreciControlThyroAB | |
| Intended use | Elecsys PreciControlThyroAB is used forquality control of theElecsys Anti-TSHRimmunoassay on theElecsys and cobas eimmunoassay analyzers. | Elecsys PreciControlThyroAB is used forquality control of theElecsys Anti-TSHR, Anti-TPO and Anti-Tgimmunoassays on theElecsys and cobas eimmunoassay analyzers. | |
| Analyteconcentration | Anti-TSHR (IU/L):Level 1 = 4Level 2 = 16 | Anti-TSHR (IU/L):Level 1 = 4Level 2 = 16Anti-TPO (IU/mL):Level 1 = 35Level 2 = 100Anti-TG (IU/mL):Level 1 = 100Level 2 = 200 | |
| Antibody sourceand type | Anti-TSHR: Humanmonoclonal | Anti-TSHR: HumanmonoclonalAnti-TPO: SheeppolyclonalAnti-TG: Sheeppolyclonal | |
| Handling | Dissolve carefully thecontents of one bottle byadding exactly 2.0 mL ofdistilled water and allowto stand closed for 15minutes to reconstitute.Mix carefully, avoidingthe formation of foam. | Dissolve carefully thecontents of one bottle byadding exactly 2.0 mL ofdistilled or deionizedwater and allow to standclosed for 30 minutes toreconstitute. Mixcarefully, avoiding theformation 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
| DeviceComparison—Differences(continued) | The table below presents the differences between the modified ElecsysPreciControl ThyroAB and the predicate device, Elecsys PreciControlThyroAB (K080092). |
|---|---|
| ----------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Characteristic | Predicate DeviceElecsys PreciControlThyroAB(K080092) | Elecsys PreciControlThyroAB |
|---|---|---|
| Stability | Unopened:Store at 2-8°C until expirationdate | Unopened:Store at 2-8°C until expirationdate |
| Reconstituted:on the analyzer at 20-25°C:up to 3 hrsat -20°C: 3 months (freezeonly once)After Thawing:use only once. | Reconstituted:on the analyzer at 20-25 °C:up to 5 hrsat -20°C: 1 month (freezeonly once)or at 2-8°C for 3 day(for Anti-TG & Anti-TPOonly) |
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
Page 1 of 1
§ 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.