(28 days)
Elecsys® PreciControl Multimarker is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
Elecsys® PreciControl Multimarker is a lyophilized product consisting of analytes in an equine serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels.
The provided text describes a 510(k) summary for the Elecsys® PreciControl Multimarker, a quality control device. The information presented focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic performance against specific acceptance criteria for a new AI/CAD device.
Therefore, many of the requested fields are not applicable in this context, as they relate to evaluating the performance of a diagnostic or AI-powered medical device against a defined ground truth, which is not the purpose of this 510(k) submission for a quality control material.
Here's an attempt to answer the questions based only on the provided text, indicating "Not Applicable" where the information is absent or irrelevant to this type of device submission:
1. A table of acceptance criteria and the reported device performance
The submission states that the device was "evaluated for value assignment, stability, and duration of reconstitution." The "Conclusion" section states, "The data demonstrate that the performance of the Elecsys® PreciControl Multimarker is substantially equivalent to that of the predicate device, Elecsys® PreciControl MultiAnalyte (K033937)."
However, specific acceptance criteria (e.g., ±X% deviation from target value, specific stability limits) and the detailed reported performance data against those criteria are not provided in this summary. The summary only states that the data demonstrate equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the summary. For a quality control material, the test set would typically be internal testing batches to establish stability and value ranges, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable or not provided. For a quality control material, "ground truth" would likely refer to certified reference materials or established assay methods used in manufacturing and testing, not expert interpretation of diagnostic images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable or not provided. Adjudication methods are relevant for subjective interpretations, typically in diagnostic imaging or clinical trials, which is not the nature of this device's evaluation.
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
This information is not applicable. This is a quality control material, not a diagnostic device intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document mentions "value assignment," "stability," and "duration of reconstitution" as evaluation points. For a quality control product, the ground truth for "value assignment" would likely be derived from a validated reference method or certified reference materials. The "ground truth" for stability would be the measurement of analyte concentrations over time under specified conditions. However, the specific methodology and type of "ground truth" (e.g., specific reference standards) are not detailed in this summary.
8. The sample size for the training set
This information is not applicable. This is a quality control material; there is no "training set" in the context of machine learning or AI. The manufacturing process of preparing control material is distinct from training an algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set.
{0}------------------------------------------------
Confidential
| SubmitterName, Address,Contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250Contact Person: Sarah BaumannPhone: 317-521-3952Fax: 317-521-2324Email: sarah.baumann@roche.comSecondary Contact: Stephanie GreemanPhone: 317-521-2458Fax: 317-521-2324Email: stephanie.greeman@roche.comDate Prepared: July 29, 2010 | AUG 27 2010 | |
|---|---|---|---|
| Device name | Proprietary name: Elecsys® PreciControl MultimarkerCommon name: PreciControl MultimarkerClassification: Multi-Analyte Controls, All Kinds (assayed and unassayed) | ||
| Devicedescription | Elecsys® PreciControl Multimarker is a lyophilized product consisting ofanalytes in an equine serum matrix. During manufacture, the analytes arespiked into the matrix at the desired concentration levels. | ||
| Predicatedevice | The Elecsys® PreciControl Multimarker is substantially equivalent to otherproducts in commercial distribution intended for similar use. We claimequivalency to the currently marketed Elecsys® MultiAnalyte (K033937). | ||
| Intended use | Elecsys® PreciControl Multimarker is used for quality control of specifiedElecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. | ||
| Continued on next page | |||
| DeviceComparison—Similarities | The table below presents the similarities between the Elecsys® PreciControlMultimarker and the predicate device, Elecsys® PreciControl MultiAnalyte(K033937). | ||
| Characteristic | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) | Elecsys® PreciControlMultimarker | |
| Analyzer system | Elecsys and cobas e | Same |
In accordance with 21 CFR 807.92, Roche Diagnostics hereby submits Introduction 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)].
. . . .
510(k) Summary— Elecsys® PreciControl Multimarker
K 102157
510(k) Summary
Elecsys® PreciControl Multimarker
{1}------------------------------------------------
Roche Diagnostics
Elecsys® PreciControl Multimarker 510(k) Summary
510(k) Summary— Elecsys® PreciControl Multimarker, Continued
Analyte
Format
Matrix
Levels
concentration
immunoassay analyzers
· C-Peptide (ng/mL)
Level 1 = 2
Level 2 = 10
Lyophilized
Two
Equine serum Same Same
Same
Same
Continued on next page
{2}------------------------------------------------
Roche Diagnostics
Elecsys® PreciControl Multimarker
510(k) Summary
510(k) Summary— Elecsys® PreciControl Multimarker, Continued
| DeviceComparison—Differences | The table below presents the differences between the Elecsys® PreciControlMultimarker and the predicate device, Elecsys® PreciControl MultiAnalyte(K033937). | ||
|---|---|---|---|
| Characteristic | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) | Elecsys® PreciControlMultimarker | |
| Intended use | PreciControl MultiAnalyteis used for quality controlof the Elecsys C-Peptideand Elecsys Insulinimmunoassays on theElecsys immunoassaysystems: | Elecsys PreciControlMultimarker is used forquality control of specifiedElecsys immunoassays onthe Elecsys and cobas eimmunoassay analyzers. | |
| Analyteconcentration | • Insulin (µU/mL)Level 1 = 20Level 2 = 100 | • Insulin (µU/mL)Level 1 = 25Level 2 = 80• ACTH (pg/mL)Level 1 = 50Level 2 = 1000• hGH (ng/mL)Level 1 = 1.00Level 2 = 10.0 | |
| Handling | Dissolve carefully thecontents of one bottle byadding exactly 2.0 mL ofdistilled water and allow tostand closed for 15 minutesto reconstitute. Mixcarefully, avoiding theformation of foam. | Dissolve carefully thecontents of one bottle byadding exactly 2.0 mL ofdistilled or deionized waterand allow to stand closed for30 minutes to reconstitute.Mix carefully, avoiding theformation of foam. |
Continued on next page
{3}------------------------------------------------
510(k) Summary— Elecsys® PreciControl Multimarker, Continued
The table below presents the differences between the Elecsys® PreciControl Device Multimarker and the predicate device, Elecsys® PreciControl MultiAnalyte Comparison-Differences (K033937). (continued)
| Characteristic | Predicate DeviceElecsys® PreciControlMultiAnalyte(K033937) | Elecsys® PreciControlMultimarker |
|---|---|---|
| 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 hrs | Reconstituted:• on the analyzer at 20-25 °C:up to 5 hrs | |
| • at -20°C: 3 months (freezeonly once) | • at -20°C: 31 days (freezeonly once) | |
| • or at 2-8°C for 72 hours | ||
| After Thawing:use only once. |
The Elecsys PreciControl Multimarker was evaluated for value assignment, Performance Characteristics stability, and duration of reconstitution. C-The data demonstrate that the performance of the Elecsys® PreciControl Conclusion Multimarker is substantially equivalent to that of the predicate device, Elecsys® PreciControl MultiAnalyte (K033937).
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows a logo with a stylized eagle or bird-like figure with outstretched wings. The logo is associated with the Department of Health, as indicated by the text surrounding the emblem. The overall design is simple and monochromatic, with a focus on the symbolic representation of the organization.
Roche Professional Diagnostics Ms. Sarah Baumann 9115 Hague Road P.O. Box 50410 Indianapolis, IN 46250-0416
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
AUG 2 7 2010
Re: K102157
Trade/Device Name: Elecsys PreciControl Multimarker Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I, Reserved Product Code: JJY Dated: July 29, 2010 Received: July 30, 2010
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 class II (Special Controls), 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). 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.
{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.
CA
Courtney C. Harper, Ph.D. Directør Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use Form
510(k) Number (if known): _ K 102157 · '
Device Name: Elecsys PreciControl Multimarker
Indications for Use: Elecsys PreciControl Multimarker is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
Over-The-Counter Use Prescription Use × Prescription Use
(Part 21 CER 801 Subpart D) AND/OR (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)
Noug Rheinheine
Division S an-Off Office of In Vitro Diagnostic Device Evaluation and Safety
长102157 510(k)
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.