(37 days)
Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. See the package insert for the list of all analytes claimed.
Elecsys® PreciControl Varia 3 is a lyophilized product consisting of analytes in a human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided 510(k) summary for the Elecsys® PreciControl Varia 3 is for a quality control material, not a diagnostic device that interprets clinical data or images. As such, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of submission.
The "study" referenced in the document is a performance evaluation demonstrating the device's suitability for its intended purpose as a quality control material, rather than a clinical study of diagnostic accuracy.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative targets. Instead, it describes performance characteristics that were evaluated to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the new device performs comparably to the legally marketed predicate devices for its intended use as a quality control material.
| Performance Characteristic | Reported Device Performance (Elecsys® PreciControl Varia 3) | Implicit Acceptance Criteria (based on Predicate Devices) |
|---|---|---|
| Value Assignment | Evaluated (details not provided) | Consistent and accurate analyte concentration values across various analytes. |
| Stability | Unopened at 2 – 8 °C: up to stated expiration dateReconstituted/thawed serum at -20 °C: 31 days (freeze only once)Reconstituted/thawed serum at 2 – 8 °C: 72 hoursReconstituted/thawed serum on-board analyzers (20 – 25 °C): up to 5 hours | Comparable or improved stability profiles (unopened, reconstituted, on-board) to predicate devices. |
| Duration of Reconstitution | Evaluated (details not provided) | Reconstitution process is effective and allows for stable control material. |
| Analyte Content | Combines analytes of Elecsys® PreciControl Anemia and Elecsys® PreciControl Bone. Specific concentrations listed in Tables 3 & 4. | Contains the specified analytes at intended concentration levels. |
| Format | Lyophilized | Matches predicate device format. |
| Matrix | Human serum | Matches predicate device matrix. |
| Levels | Three | Matches predicate device levels. |
| Traceability | Vitamin B12—Commercially available radio-binding assay; Ferritin—NIBSC Standard 80/602; Folate—Elecsys Folate II Assay; β-CrossLaps/serum (β-CTx)—Gravimetry; Osteocalcin—In-house reference system; Parathyroid Hormone (PTH and PTH STAT)—In-house reference system | Traceability comparable to predicate devices for accurate assay calibration and quality control. |
| Intended Use | Quality control of specified Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. | Meets the quality control function for the specified immunoassay platforms. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The evaluation was for the performance of the control material itself (value assignment, stability, reconstitution), rather than its performance in detecting specific patient conditions.
- Data Provenance: Not specified in terms of country of origin. The study appears to be a laboratory validation of the control material's characteristics, likely conducted internally by Roche Diagnostics. It would be a prospective study in the sense of evaluating the manufactured control material.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a quality control material, "ground truth" is established by the accurate assignment of analyte concentrations during manufacturing, often traceable to international standards or well-characterized reference materials and methods.
- Qualifications of Experts: N/A.
4. Adjudication method for the test set
- Adjudication Method: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: Not applicable. This device is a quality control material, not a diagnostic imaging or AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a laboratory reagent, not an algorithm. Its "performance" refers to its chemical and biological stability and accurately assigned values.
7. The type of ground truth used
- Type of Ground Truth: For the analyte concentrations, the ground truth is established through:
- Reference materials/standards: e.g., NIBSC Standard 80/602 for Ferritin.
- Commercially available assays: e.g., radio-binding assay for Vitamin B12.
- Gravimetry: e.g., for β-CrossLaps/serum.
- In-house reference systems: developed and calibrated against established methods or standards for Osteocalcin and PTH.
Essentially, the "ground truth" for a quality control material is its accurately characterized and assigned analyte concentrations.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable.
{0}------------------------------------------------
Roche Diagnostics
RMS 00
Elecsys® PreciControl Varia 3
510(k) Summary
510(k) Summary— Elecsys® PreciControl Varia 3
JUL - 8 - 2011
| 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.com | |
| Date Prepared: May 31, 2011 | |
| Device name | Proprietary name: Elecsys® PreciControl Varia 3Common name: PreciControl Varia 3Classification: Multi-Analyte Controls, All Kinds (assayed and unassayed) |
| Devicedescription | Elecsys® PreciControl Varia 3 is a lyophilized product consisting of analytesin a human serum matrix. During manufacture, the analytes are spiked intothe matrix at the desired concentration levels. |
| Predicatedevices | Elecsys® PreciControl Varia 3 is substantially equivalent to other products incommercial distribution intended for similar use. We claim equivalency to thecurrently marketed Elecsys® PreciControl Anemia (K082340) and Elecsys®PreciControl Bone (K051543). |
| Elecsys® PreciControl Varia 3 is a multi-analyte control that combines theanalytes in the Elecsys® PreciControl Anemia (K082340) and Elecsys®PreciControl Bone (K051543) multi-analyte controls. | |
| Continued on next page | |
| Intended use | Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. |
| DeviceComparison—Similarities | Elecsys® PreciControl Varia 3 is a multi-analyte control that combines the analytes in the Elecsys® PreciControl Anemia (K082340) and Elecsys® PreciControl Bone (K051543) multi-analyte controls. |
| Tables 1 and 2 below present the similarities between Elecsys® PreciControl Varia 3 and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 1) and Elecsys® PreciControl Bone (K051543, Table 2). |
{1}------------------------------------------------
| Table 1. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsyse | ||
|---|---|---|
| PreciControl Anemia)-Similarities | ||
| Characteristic | Candidate DeviceElecsys® PreciControl Varia 3 | Predicate DeviceElecsys® PreciControl Anemia(K082340) |
| Analyzersystem | Elecsys and cobas e immunoassayanalyzers | Same |
| Format | Lyophilized | Same |
| Matrix | Human serum | Same |
| Levels | Three | Same |
| Traceability | • Vitamin B12—Commercially availableradio-binding assay• Ferritin—NIBSC Standard 80/602• Folate—Elecsys Folate II Assay | Same |
{2}------------------------------------------------
Tables 1 and 2 present the similarities between Elecsys® PreciControl Varia 3 Device and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 1) Comparison-Similarities and Elecsys® PreciControl Bone (K051543, Table 2). (continued)
Table 2. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Bone)-Similarities
| Characteristic | Candidate DeviceElecsys® PreciControl Varia 3 | Predicate DeviceElecsys® PreciControl Bone(K051543) |
|---|---|---|
| Analyzersystem | Elecsys and cobas e immunoassayanalyzers | Same |
| Format | Lyophilized | Same |
| Levels | Three | Same |
| Traceability | • β-CrossLaps/serum (β-CTx)—Gravimetry• Osteocalcin—In-house referencesystem (commercially availableosteocalcin immuno/radio-bindingassay)• Parathyroid Hormone (PTH and PTHSTAT)—In-house reference system(commercially available PTH radio-binding assay) | Same |
{3}------------------------------------------------
Elecsys® PreciControl Varia 3 is a multi-analyte control that combines the Device analytes in the Elecsys® PreciControl Anemia (K082340) and Elecsys® Comparison-Differences PreciControl Bone (K051543) multi-analyte controls.
Tables 3 and 4 below present the differences between Elecsys® PreciControl Varia 3 and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) and Elecsys® PreciControl Bone (K051543, Table 4).
Table 3. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Anemia)—Differences
| Characteristic | Candidate DeviceElecsys® PreciControl Varia 3 | Predicate DeviceElecsys® PreciControl Anemia(K082340) |
|---|---|---|
| Intended use | Elecsys PreciControl Varia 3 is usedfor quality control of specified Elecsysimmunoassays on the Elecsys andcobas e immunoassay analyzers. | Elecsys PreciControl Anemia isused for quality control of Elecsysimmunoassays on the Elecsys andcobas e immunoassay analyzers. |
| Analyteconcentration | Ferritin (ng/mL)Level 0 = 14Level 1 = 150Level 2 = 1000 Folate (ng/mL)Level 0 = N/ALevel 1 = 3.9Level 2 = 12 Vitamin B12 (pg/mL)Level 0 = 230Level 1 = 500Level 2 = 1000 | Ferritin (ng/mL)Level 1 = 15Level 2 = 500Level 3 = 1500 Folate (ng/mL)Level 1 = 3Level 2 = 8Level 3 = 14 Vitamin B12 (pg/mL)Level 1 = 350Level 2 = 700Level 3 = 1500 |
| Handling | Dissolve carefully the contents of onebottle by adding exactly 3.0 mL ofdistilled or deionized water and allowto stand closed for 30 minutes toreconstitute. Mix carefully, avoidingthe formation of foam. | Dissolve carefully the contents ofone bottle by adding exactly 2.0 mLof distilled or deionized water andallow to stand closed for 30 minutesto reconstitute. Mix carefully,avoiding the formation of foam. |
| Volume(reconstituted) | 3.0 mL | 2.0 mL |
{4}------------------------------------------------
Tables 3 and 4 present the differences between Elecsys® PreciControl Varia 3 Device and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) Comparison-Differences and Elecsys® PreciControl Bone (K051543, Table 4). (continued)
and the comments of the comments of the comments of the comments of the comments of the comments of
Table 3. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Anemia)-Differences, continued
| Characteristic | Candidate DeviceElecsys® PreciControl Varia 3 | Predicate DeviceElecsys® PreciControl Anemia(K082340) |
|---|---|---|
| Stability | Unopened at 2 - 8 °C:up to the stated expiration date | Unopened at 2 - 8 °C:up to the stated expiration date |
| Reconstituted/thawed serum:o at - 20 °C: 31 days (freeze only once)o at 2 – 8 °C: 72 hourso at 20 – 25 °C on-board the analyzers: up to 5 hours | Reconstituted serum:o at - 20 °C: 1 month (freeze only once)o at 2 - 8 °C: 3 dayso at 20 – 25 °C on-board the analyzers: up to 5 hourso at 20 – 25 °C: up to 8 hours after thawing: use only once |
{5}------------------------------------------------
Tables 3 and 4 present the differences between Elecsys® PreciControl Varia 3 Device Comparisonand the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) Differences and Elecsys® PreciControl Bone (K051543, Table 4). (continued)
のお気になる。
Table 4. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsys® PreciControl Bone)-Differences
| Characteristic | Candidate DeviceElecsys® PreciControl Varia 3 | Predicate DeviceElecsys® PreciControl Bone(K051543) |
|---|---|---|
| Intended use | Elecsys PreciControl Varia 3 is usedfor quality control of specified Elecsysimmunoassays on the Elecsys andcobas e immunoassay analyzers. | Elecsys PreciControl Bone is usedfor quality control of Elecsysimmunoassays on the Elecsys andcobas e immunoassay analyzers. |
| Analyteconcentration | $\beta$ -CTx (pg/mL)Level 0 = N/ALevel 1 = 320Level 2 = 750 Osteocalcin (ng/mL)Level 0 = N/ALevel 1 = 20Level 2 = 100 PTH (pg/mL)Level 0 = 25Level 1 = 60Level 2 = 200 | $\beta$ -CTx (pg/mL)Level 1 = 315Level 2 = 750Level 3 = 3000 Osteocalcin (ng/mL)Level 1 = 20Level 2 = 100Level 3 = 205 PTH (pg/mL)Level 1 = 60Level 2 = 205Level 3 = 850 |
| Handling | Dissolve carefully the contents of onebottle by adding exactly 3.0 mL ofdistilled or deionized water and allowto stand closed for 30 minutes toreconstitute. Mix carefully, avoidingthe formation of foam. | Dissolve carefully the contents ofone bottle by adding exactly 2.0 mLof distilled or deionized water andallow to stand closed for 15 minutesto reconstitute. Mix carefully,avoiding the formation of foam. |
{6}------------------------------------------------
Tables 3 and 4 present the differences between Elecsys® PreciControl Varia 3 Device and the predicate devices, Elecsys® PreciControl Anemia (K082340, Table 3) Comparison-Differences and Elecsys® PreciControl Bone (K051543, Table 4). (continued)
Table 4. Comparison of Candidate (Elecsys® PreciControl Varia 3) and Predicate (Elecsyse PreciControl Bone)—Differences, continued
| Characteristic | Candidate DeviceElecsys® PreciControl Varia 3 | Predicate DeviceElecsys® PreciControl Bone(K051543) |
|---|---|---|
| Volume(reconstituted) | 3.0 mL | 2.0 mL |
| Stability | Unopened at 2 – 8 °C:up to the stated expiration dateReconstituted/thawed serum:o at – 20 °C: 31 days (freeze onlyonce)o at 2 – 8 °C: 72 hourso at 20 – 25 °C on-board theanalyzers: up to 5 hours | Unopened at 2 – 8 °C:up to the stated expiration dateReconstituted/thawed serum:o at – 20 °C: 1 month (4freeze/thaw cycles possible)o at 2 – 8 °C: 5 dayso at 20 – 25 °C: up to 8 hours |
| Performance | Elecsys® PreciControl Varia 3 was evaluated for value assignment, stability,and duration of reconstitution. |
|---|---|
| Characteristics | |
| Conclusion | The data demonstrate that the performance of Elecsys® PreciControl Varia 3is substantially equivalent to that of the predicate devices, Elecsys®PreciControl Anemia (K082340) and Elecsys® PreciControl Bone (K051543). |
{7}------------------------------------------------
Image /page/7/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
JUL 0 8 2011
Roche Diagnostics c/o Sarah Baumann Regulatory Affairs Consultant 9115 Hague Road P.O. Box 50410 Indianapolis. IN, 46250-0416
Re: K111506
Trade Name: Elecsys PreciControl Varia 3 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality Control Material Regulatory Class: Class I, Reserved Product Code: JJY Dated: May 31, 2011 Received: June 1, 2011
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).
{8}------------------------------------------------
Page 2 --
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (01) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premyaket notification" (21 CFR 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/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 tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours.
CJC.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: 评论:
Enclosure
{9}------------------------------------------------
Indications for Use Form
510(k) Number (if known): K11 | 500
Device Name: Elecsys® PreciControl Varia 3
Indications for Use:
Elecsys® PreciControl Varia 3 is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. See the package insert for the list of all analytes claimed.
X Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110506
§ 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.