(37 days)
Not Found
No
The summary describes a quality control material for immunoassay analyzers, which is a chemical reagent product, not a software or hardware device that would typically incorporate AI/ML. The description focuses on the composition and performance evaluation of the control material itself.
No
The device is a quality control product for immunoassays, not a device used to treat or diagnose patients. Its purpose is to ensure the accuracy of other diagnostic tests.
No
This device is described as a "lyophilized product consisting of analytes in a human serum matrix" used for "quality control of specified Elecsys immunoassays." It aids in ensuring the accuracy of diagnostic tests by controlling for their proper function, rather than directly diagnosing conditions.
No
The device description explicitly states it is a "lyophilized product consisting of analytes 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 is "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 and measure substances in biological samples. Quality control materials are essential for ensuring the accuracy and reliability of these in vitro tests.
- Device Description: The description mentions it's a "lyophilized product consisting of analytes in a human serum matrix." This indicates it's a reagent or material used in a laboratory setting for testing biological samples.
- Predicate Devices: The predicate devices listed (Elecsys® PreciControl Anemia and Elecsys® PreciControl Bone) are also quality control materials for in vitro diagnostic tests.
All these points strongly indicate that the Elecsys® PreciControl Varia 3 is a device used in vitro for diagnostic purposes (specifically, for quality control of diagnostic tests).
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
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.
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)
Elecsys® PreciControl Varia 3 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
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 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: May 31, 2011 |
| Device name | Proprietary name: Elecsys® PreciControl Varia 3
Common name: PreciControl Varia 3
Classification: Multi-Analyte Controls, All Kinds (assayed and unassayed) |
| Device
description | 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. |
| Predicate
devices | Elecsys® PreciControl Varia 3 is substantially equivalent to other products in
commercial distribution intended for similar use. We claim equivalency to the
currently marketed Elecsys® PreciControl Anemia (K082340) and Elecsys®
PreciControl Bone (K051543). |
| | 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. |
| | 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. |
| Device
Comparison—
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 Device | |
| Elecsys® PreciControl Varia 3 | Predicate Device | |
| Elecsys® PreciControl Anemia | ||
| (K082340) | ||
| Analyzer | ||
| system | Elecsys and cobas e immunoassay | |
| analyzers | Same | |
| Format | Lyophilized | Same |
| Matrix | Human serum | Same |
| Levels | Three | Same |
| Traceability | • Vitamin B12—Commercially available | |
| radio-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 Device
Elecsys® PreciControl Varia 3 | Predicate Device
Elecsys® PreciControl Bone
(K051543) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Analyzer
system | Elecsys and cobas e immunoassay
analyzers | Same |
| Format | Lyophilized | Same |
| Levels | Three | Same |
| Traceability | • β-CrossLaps/serum (β-CTx)—
Gravimetry
• Osteocalcin—In-house reference
system (commercially available
osteocalcin immuno/radio-binding
assay)
• Parathyroid Hormone (PTH and PTH
STAT)—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 Device
Elecsys® PreciControl Varia 3 | Predicate Device
Elecsys® PreciControl Anemia
(K082340) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys PreciControl Varia 3 is used
for quality control of specified Elecsys
immunoassays on the Elecsys and
cobas e immunoassay analyzers. | Elecsys PreciControl Anemia is
used for quality control of Elecsys
immunoassays on the Elecsys and
cobas e immunoassay analyzers. |
| Analyte
concentration | Ferritin (ng/mL)
Level 0 = 14
Level 1 = 150
Level 2 = 1000 Folate (ng/mL)
Level 0 = N/A
Level 1 = 3.9
Level 2 = 12 Vitamin B12 (pg/mL)
Level 0 = 230
Level 1 = 500
Level 2 = 1000 | Ferritin (ng/mL)
Level 1 = 15
Level 2 = 500
Level 3 = 1500 Folate (ng/mL)
Level 1 = 3
Level 2 = 8
Level 3 = 14 Vitamin B12 (pg/mL)
Level 1 = 350
Level 2 = 700
Level 3 = 1500 |
| Handling | Dissolve carefully the contents of one
bottle by adding exactly 3.0 mL of
distilled or deionized water and allow
to stand closed for 30 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. |
| 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 Device
Elecsys® PreciControl Varia 3 | Predicate Device
Elecsys® 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 hours
o 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 days
o at 20 – 25 °C on-board the analyzers: up to 5 hours
o 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 Device
Elecsys® PreciControl Varia 3 | Predicate Device
Elecsys® PreciControl Bone
(K051543) |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys PreciControl Varia 3 is used
for quality control of specified Elecsys
immunoassays on the Elecsys and
cobas e immunoassay analyzers. | Elecsys PreciControl Bone is used
for quality control of Elecsys
immunoassays on the Elecsys and
cobas e immunoassay analyzers. |
| Analyte
concentration | $\beta$ -CTx (pg/mL)
Level 0 = N/A
Level 1 = 320
Level 2 = 750 Osteocalcin (ng/mL)
Level 0 = N/A
Level 1 = 20
Level 2 = 100 PTH (pg/mL)
Level 0 = 25
Level 1 = 60
Level 2 = 200 | $\beta$ -CTx (pg/mL)
Level 1 = 315
Level 2 = 750
Level 3 = 3000 Osteocalcin (ng/mL)
Level 1 = 20
Level 2 = 100
Level 3 = 205 PTH (pg/mL)
Level 1 = 60
Level 2 = 205
Level 3 = 850 |
| Handling | Dissolve carefully the contents of one
bottle by adding exactly 3.0 mL of
distilled or deionized water and allow
to stand closed for 30 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 15 minutes
to 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 Device
Elecsys® PreciControl Varia 3 | Predicate Device
Elecsys® PreciControl Bone
(K051543) |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Volume
(reconstituted) | 3.0 mL | 2.0 mL |
| Stability | 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 hours
o at 20 – 25 °C on-board the
analyzers: up to 5 hours | Unopened at 2 – 8 °C:
up to the stated expiration date
Reconstituted/thawed serum:
o at – 20 °C: 1 month (4
freeze/thaw cycles possible)
o at 2 – 8 °C: 5 days
o 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 3
is 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