(57 days)
Bio-Rad Lyphochek Immunoassay Plus Control
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No
The document describes a quality control material (lyophilized serum) for immunoassay systems and does not mention any AI or ML components.
No.
Explanation: The device is a quality control product used to monitor the accuracy and precision of immunoassay systems, not to treat a disease or condition in a patient.
No
This device is a quality control material used to monitor the accuracy and precision of Elecsys immunoassays, not a device that directly diagnoses a condition.
No
The device description explicitly states that the device "contains lyophilized control serum based on human serum," indicating it is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that it is used for "quality control of Elecsys immunoassays." Immunoassays are laboratory tests performed in vitro (outside the body) to measure the presence or concentration of substances in biological samples. Quality control materials are essential for ensuring the accuracy and reliability of these in vitro tests.
- Device Description: The description confirms it is a "lyophilized control serum based on human serum." Control materials are used in laboratory settings to verify the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device" which is also a control material for immunoassays further supports its classification as an IVD. Predicate devices are used to demonstrate substantial equivalence for regulatory purposes, and they are typically devices with similar intended uses and technological characteristics.
Therefore, based on the provided information, PreciControl Tumor Marker fits 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 using the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Bio-Rad Lyphochek Immunoassay Plus Control
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.
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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).
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§ 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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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. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Boehringer Mannheim Corporation
9115 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) Predicate
device | We claim substantial equivalence to Bio-Rad Lyphochek Immunoassay Plus
Control. |
| 4) 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. |
| | 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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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)