(57 days)
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 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.
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.
This 510(k) submission is for a quality control material (PreciControl Tumor Marker), not a diagnostic device that directly assesses patient conditions. Therefore, many of the typical acceptance criteria and study components related to diagnostic accuracy (like sensitivity, specificity, reader studies, etc.) are not applicable in the usual sense.
The submission focuses on demonstrating substantial equivalence to a predicate quality control material, primarily by showing it performs its intended function (monitoring accuracy and precision of immunoassays) comparably. The "performance" here relates to its ability to serve as a reliable control, not to diagnose a disease.
Based on the provided text, here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or present a table of reported device performance in the way a diagnostic device submission might. Instead, it claims substantial equivalence based on the intended use and nature of the device.
The "performance" implied for a quality control material is its ability to:
- Contain lyophilized control serum with concentrations in two clinically relevant ranges.
- Be used for monitoring the accuracy and precision of Elecsys immunoassays.
The device meets these general performance characteristics as described.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of patient data. For a quality control material, testing would involve internal studies to characterize its stability, homogeneity, and assigned values. This information is not detailed in the provided K972235 summary.
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)
Not applicable. This device is a quality control material, not a diagnostic device requiring expert interpretation of patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a quality control material, the "ground truth" would relate to the assigned values for the analytes within the control. These values are typically established through rigorous manufacturing processes, reference methods, and inter-laboratory studies. The document does not provide details on how these specific values were assigned for PreciControl Tumor Marker.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses a training set of data.
9. How the ground truth for the training set was established
Not applicable.
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510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| 1) Submittername, address,contact | Boehringer Mannheim Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000 |
| Contact Person: LeeAnn Chambers, RAC | |
| Date Prepared: June 13, 1997 | |
| 2) Device name | Proprietary name: PreciControl Tumor Marker |
| Common name: Quality Control Material | |
| Classification name: Multi-Analyte Control, all kinds, (assayed + unassayed) | |
| 3) Predicatedevice | We claim substantial equivalence to Bio-Rad Lyphochek Immunoassay PlusControl. |
| 4) DeviceDescription | PreciControl Tumor Marker contains lyophilized control serum based onhuman serum. The concentrations are in two clinically relevant ranges. Thecontrols are used for monitoring the accuracy and precision of Elecsysimmunoassays. |
| Continued on next page |
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510(k) Summary, Continued
1
f
K972235
| 5) Intended use | PreciControl Tumor Marker is used for quality control of Elecsys immunoassays using the Elecsys immunoassay systems. |
|---|---|
| 6) Comparison to predicate device | The Boehringer Mannheim PreciControl Tumor Marker is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Bio-Rad Lyphochek Immunoassay Plus Control.The intended use of both the PreciControl Tumor Marker and the predicate device are the same in that they are intended to estimate test precision and detect systematic analytical deviations on automated immunoassay systems. |
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. LeeAnn Chambers, RAC Program Manager, Regulatory Affairs Boehringer Mannheim Corporation 9115 Haque Road Indianapolis, Indiana 46250
AUG 1 2 1997
Re: K972235 Trade Name: PreciControl Tumor Marker Requlatory Class: I Product Code: JJY Dated: June 13, 1997 Received: June 16, 1997
Dear Ms. Chambers:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K972235 Device Name: PreciControl Tumor Marker Indications for 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 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.
ﺮ ﺍﻟﻤﺴﺎﺑﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺗﺮﺗﺒﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍﻟﺘﻲ ﺍ
Peter E. Machin
(Division Sign Off)
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use
(Per 21 CFR 801.109)
책은 문
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.