(28 days)
Not Found
No
The summary describes a quality control product for immunoassay analyzers, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a quality control product for immunoassays, not a device used to treat or cure a disease.
No
Explanation: The device is a quality control product used to ensure the accuracy of immunoassay analyzers, not to diagnose medical conditions in patients. It's used for quality assurance of other diagnostic devices.
No
The device description explicitly states it is a "lyophilized product consisting of analytes in an equine 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 used for "quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers." Immunoassays are laboratory tests performed in vitro (outside the body) to detect or measure substances in biological samples. Quality control materials are essential for ensuring the accuracy and reliability of these in vitro diagnostic tests.
- Device Description: The description mentions it's a "lyophilized product consisting of analytes in an equine serum matrix." This describes a reagent used in laboratory testing.
- Performance Studies: The summary of performance studies discusses evaluation for "value assignment, stability, and duration of reconstitution," which are typical evaluations for IVD quality control materials.
- Predicate Device: The mention of a predicate device (K033937; Elecsys® MultiAnalyte) which is also an IVD quality control material, further confirms the device's classification.
While the document doesn't mention image processing, AI, DNN, or ML, and doesn't provide details about patient age, anatomical site, or user setting (which are often relevant for diagnostic devices used directly on patients), the core function of providing quality control for in vitro diagnostic tests clearly places it within the IVD category.
N/A
Intended Use / Indications for Use
Elecsys® PreciControl Multimarker is used for quality control of specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Applicable
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 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).
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
Confidential
| 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 29, 2010 | AUG 27 2010 | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------|
| Device name | Proprietary name: Elecsys® PreciControl Multimarker
Common name: PreciControl Multimarker
Classification: Multi-Analyte Controls, All Kinds (assayed and unassayed) | | |
| Device
description | 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. | | |
| Predicate
device | The Elecsys® PreciControl Multimarker is substantially equivalent to other
products in commercial distribution intended for similar use. We claim
equivalency to the currently marketed Elecsys® MultiAnalyte (K033937). | | |
| Intended use | Elecsys® PreciControl Multimarker is used for quality control of specified
Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. | | |
| | Continued on next page | | |
| Device
Comparison—
Similarities | The table below presents the similarities between the Elecsys® PreciControl
Multimarker and the predicate device, Elecsys® PreciControl MultiAnalyte
(K033937). | | |
| | Characteristic | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) | Elecsys® PreciControl
Multimarker |
| | 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
| Device
Comparison—
Differences | The table below presents the differences between the Elecsys® PreciControl
Multimarker and the predicate device, Elecsys® PreciControl MultiAnalyte
(K033937). | | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Characteristic | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) | Elecsys® PreciControl
Multimarker |
| | Intended use | PreciControl MultiAnalyte
is used for quality control
of the Elecsys C-Peptide
and Elecsys Insulin
immunoassays on the
Elecsys immunoassay
systems: | Elecsys PreciControl
Multimarker is used for
quality control of specified
Elecsys immunoassays on
the Elecsys and cobas e
immunoassay analyzers. |
| | Analyte
concentration | • Insulin (µU/mL)
Level 1 = 20
Level 2 = 100 | • Insulin (µU/mL)
Level 1 = 25
Level 2 = 80
• ACTH (pg/mL)
Level 1 = 50
Level 2 = 1000
• hGH (ng/mL)
Level 1 = 1.00
Level 2 = 10.0 |
| | 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. |
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 Device
Elecsys® PreciControl
MultiAnalyte
(K033937) | Elecsys® PreciControl
Multimarker |
|----------------|------------------------------------------------------------------------|-----------------------------------------------------------------|
| 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 | Reconstituted:
• on the analyzer at 20-25 °C:
up to 5 hrs |
| | • at -20°C: 3 months (freeze
only once) | • at -20°C: 31 days (freeze
only 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)
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