(69 days)
Not Found
No
The summary describes a quality control material for immunoassay systems and does not mention any AI or ML components.
No
This device is a quality control product for immunoassays, used to monitor the accuracy and precision of diagnostic tests, not to treat a medical condition.
No
Explanation: The device is described as a quality control material used for monitoring the accuracy and precision of immunoassay systems, not for diagnosing conditions in patients. It's used for analytical quality control of other diagnostic devices.
No
The device description clearly states that the device contains lyophilized control serum based on human serum, indicating it is a physical reagent, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that PreciControl Tumor Marker is used for "quality control of Elecsys immunoassays on Elecsys immunoassay systems." This is a classic function of an IVD, which are used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment. In this case, the control is used to ensure the accuracy and precision of the immunoassay, which is itself an IVD used to test human samples.
- Device Description: The description mentions it contains "lyophilized control serum based on human serum." This indicates it's a reagent or material used in an in vitro test.
- Predicate Device: The mention of a predicate device (K972235; Elecsys® PreciControl Tumor Marker) further supports its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
While the document doesn't provide details about patient age, anatomical site, or user setting, the core function of being a quality control for an immunoassay that tests human samples firmly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
Product codes
JJY
Device Description
PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
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
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Summary of Performance Studies
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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.
0
510(k) Summary - Elecsys® PreciControl Tumor Marker
| 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 Corporation |
| 9115 Hague Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3831 | |
| Contact person: Kay A. Taylor | |
| Date prepared: February 14, 2005 | |
| Device Name | Proprietary name: Roche Diagnostics Elecsys® PreciControl Tumor Marker |
| Common name: Quality Control Material | |
| Classification name: Multi-analyte Controls (assayed and unassayed) | |
| Device description | PreciControl Tumor Marker contains lyophilized control serum based on human serum. The concentrations are in two clinically relevant ranges. The controls are used for monitoring the accuracy and precision of Elecsys immunoassays. |
| Intended use | PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems. |
| Predicate Device | We claim substantial equivalence to the currently marketed Elecsys® PreciControl Tumor Marker (K972235). |
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510(k) Summary - Elecsys® PreciControl Tumor Marker,
continued
The table below indicates the similarities between the modified Elecsys® Device Comparison PreciControl Tumor Marker and the current device.
| Topic | Elecsys® PreciControl Tumor
Marker
(K972235) | Elecsys® PreciControl Tumor
Marker
(Modified Device) |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | PreciControl Tumor Marker is used
for quality control of Elecsys
immunoassays using the Elecsys
immunoassay systems (Elecsys 2010,
1010 and others of the Elecsys family
of instruments). | PreciControl Tumor Marker is used
for quality control of Elecsys
immunoassays on Elecsys
immunoassay systems. |
| Analyzer
System | Elecsys® immunoassay analyzers | Same |
| Reagent
Format | lyophilized, based on human serum | Same |
| Analyte
Concentration
PC TM1 / PC
TM2 | AFP: approx. 8 & 100 IU/ml
CEA: approx. 5 & 50 ng/ml
CA 15-3 II: approx. 20 & 100 U/mL
CA 125 II: approx. 35 & 100 U/mL
Ferritin: approx. 25 & 200 ng/mL
fPSA: approx. 1 & 10 ng/mL
tPSA: approx. 4 & 40 ng/mL | AFP: approx. 8 & 100 IU/ml
CEA: approx. 5 & 50 ng/ml
CA 15-3 II: approx. 20 & 100 U/mL
CA 125 II: approx. 35 & 100 U/mL
Ferritin: approx. 25 & 200 ng/mL
fPSA: approx. 1 & 10 ng/mL
tPSA: approx. 4 & 40 ng/mL
CA 19-9: approx. 20 & 100 U/mL, |
| Stability | @ 2-8° C
• unopened until expiration date
• opened for 2 weeks
@ 20-25° C
• on the analyzers, up to 5
hours
• 24 hours
@ -20° C
• 1 month (freeze only once)
months at -20° C (only freeze once) | Same |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and tail feathers. The eagle is facing right and appears to be in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
APR 2 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Ms. Kay A. Taylor Regulatory Affairs Principal Centralized Diagnostics 9115 Hague Rd. Indianapolis, IN 46250
Re: K050387
Trade/Device Name: Elecsys PreciControl Tumor Marker Regulation Number: 21 CFR 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: Class I Product Code: JJY Dated: February 14, 2005 Received: February 15, 2005
Dear Ms. Taylor:
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 prover to the ready 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advisour that 227 » ination 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 Part 801); good manufacturing practice requirements as set forth in the quality labeling (21 CFR Part 800), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 – Ms Kay A. Taylor
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 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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0131. 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/dsma/dsmamaif.html
Sincerely yours,
Lobert Becker/
Robert L. Becker, Jr., M.D., PhD Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Ko502
Device Name: Elecsys PreciControl Tumor Marker
Indications For Use:
PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys immunoassay systems.
The controls are used for monitoring the accuracy and precision of Elecsys immunoassays.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
In chan
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) K050287