(27 days)
Not Found
No
The summary describes a quality control product for immunoassay systems, which is a chemical reagent, not a software or hardware device that would typically incorporate AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is a quality control product for immunoassays, not a device used for treating disease.
No
The device is described as a quality control product for immunoassays, not a device used to diagnose a patient's condition.
No
The device description clearly states it is a lyophilized product consisting of added substances in a human serum matrix, indicating it is a physical reagent, not software.
Based on the provided information, the Elecsys® PreciControl Anemia is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems." This indicates it's used in vitro (outside the body) to assess the performance of other diagnostic tests.
- Device Description: It's a "lyophilized product consisting of added Ferritin and Aprotinine in human serum matrix." This describes a reagent or control material used in laboratory testing.
- Purpose: Quality control materials are essential components of IVD testing to ensure the accuracy and reliability of the results.
Therefore, the Elecsys® PreciControl Anemia fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.
Product codes
JJY
Device Description
The Elecsys® PreciControl Anemia is a lyophilized product consisting of added Ferritin and Aprotinine in 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
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Intended User / Care Setting
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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
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Summary of Performance Studies
The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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| JUL | 5 - 2005 |
|---|---|
| ----- | ---------- |
and the comments of the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the
K 05/5/17
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| Submitter name, address, contact | Roche Diagnostics |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| 317-521-3723 |
Contact Person: Corina Harper
Date Prepared: Jun 6, 2005 |
| Device Name | Proprietary name: Elecsys® PreciControl Anemia
Common name: PreciControl Anemia
Classification name: The FDA has classified Multi-Analyte Controls, All Kinds (assayed and unassayed) in Class I. |
| Predicate device | The Elecsys® PreciControl Anemia is substantially equivalent to the currently marketed Elecsys® PreciControl MultiAnalyte (K033937). |
| Device Description | The Elecsys® PreciControl Anemia is a lyophilized product consisting of added Ferritin and Aprotinine in human serum matrix. During manufacture, the analytes are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems. |
| | Continued on next page |
:
1
510(k) Summary, Continued
| Comparison to The Elecsys® PreciControl Anemia is substantially equivalent to the | |
|---|---|
| predicate device | currently marketed Elecsys® PreciControl MultiAnalyte (K033937). The |
| below tables compare Elecsys® PreciControl Anemia with the predicate device, Elecsys® PreciControl MultiAnalyte (K033937). |
Similarities
| Characteristic | Elecsys® PreciControl
Anemia | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys® PreciControl
Anemia is used for quality
control of the Elecsys®
Ferritin, Folate II, and
Vitamin B12 immunoassays
on the Elecsys®
immunoassay systems. | Elecsys® PreciControl
MultiAnalyte is used for
quality control of the Elecsys®
C-Peptide and Elecsys Insulin
immunoassays on the
Elecsys® immunoassay
systems. |
| Levels | Three | Two |
| Format | Lyophilized | same |
| Handling | Reconstitute with exactly 2.0
mL of distilled water and
allow to stand closed for 30
minutes to reconstitute, and
then mix gently. | Reconstitute with exactly 2.0
mL of distilled water and allow
to stand closed for 15 minutes
to reconstitute, and then mix
gently. |
| Stability | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• 20 - 25 °C: up to 8 hrs
• on the analyzers at 20-
25°C: up to 5 hrs
• at 2-8°C: 3 days
• at -20°C: 1 month (freeze
only once)
• after thawing: use only
once | Unopened:
• Store at 2-8°C until
expiration date
Reconstituted:
• on the analyzers at 20-25°C:
up to 3 hrs
• at -20°C: 1 month (freeze
only once)
• after thawing: use only once |
Continued on next page
Roche Diagnostics Confidential
2
510(k) Summary, Continued
| Characteristic | Elecsys® PreciControl
Anemia | Predicate Device
Elecsys® PreciControl
MultiAnalyte
(K033937) |
|----------------|-------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Matrix | Human serum with added
Ferritin (human origin) and
Aprotinine (bovine origin) | Equine serum with added
C-Peptide and insulin |
The Elecsys® PreciControl Anemia was evaluated for value assignment and Performance Characteristics stability.
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3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Public Health Service
Ms. Corina Harper, RAC Regulatory Affairs Consultant Centralized Diagnostics Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
JUL 5 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Re: K051517
Trade/Device Name: Elecsys® PreciControl Anemia Regulation Number: 21 CFR 862.1660 Regulation Name: Multi-Analyte controls all kinds (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: June 6, 2005 Received: June 8, 2005
Dear Ms. Harper:
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 vour 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benam
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K051517
Device Name:
Elecsys® PreciControl Anemia
Indications For Use:
Elecsys® PreciControl Anemia is used for quality control of the Elecsys® Ferritin, Folate II, and Vitamin B12 immunoassays on the Elecsys® immunoassay systems.
Prescription Use XXXX (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
K
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number
Roche Diagnostics Confidential
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