(34 days)
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No
The document describes a quality control serum for laboratory testing and does not mention any AI or ML components.
No
This device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," suggesting it's used for quality control in lab tests, not for treating patients.
No
The device is described as an "assayed quality control serum to monitor the precision of laboratory testing procedures," indicating it is used for quality control, not for diagnosing patients.
No
The device is a lyophilized serum control, which is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is "intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert." This clearly indicates it is used in vitro (outside the body) to assess the performance of diagnostic tests.
- Device Description: It is a "quality control serum" used in "laboratory testing procedures."
- Predicate Device: The mention of a predicate device (K990610; Abbott Tumor Marker - MCC (Lyophilized)) further supports its classification as a medical device, and specifically an IVD, as predicate devices are used for comparison in regulatory submissions for new devices, including IVDs.
The device is a control material used in vitro to ensure the accuracy and precision of laboratory tests, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
Abbott Tumor Marker - MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.
Product codes
75JJY
Device Description
Abbott Tumor Marker - MCC (Lyophilized) is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability
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)
Stability studies have been performed to determine the open vial stability and shelf life for the Abbott Tumor Marker - MCC (Lyophilized). Product claims are as follows:
- Once the control is reconstituted, all analytes will be stable for 14 days 7.1 when stored tightly capped at 2 - 8℃, with the following exceptions: Free PSA and PSA should be assayed immediately following reconstitution.
- After reconstituting and freezing the control, all analytes will be stable for 7.2 30 days when stored tightly capped at -10℃ to -20℃. Once thawed, do not refreeze the control; discard remaining material.
- The control is stable for 3 years and 3 months when stored unopened at 2 7.3 - 8℃.
Real time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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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Bio-Rad Laboratories Premarket Notification Section 510(k) for Abbott Turnor Marker -- MCC (Lyophilized) Summary of Safety and Effectiveness
711853
Page 1 of 3
Summary of Safety and Effectiveness Abbott Tumor Marker - MCC (Lyophilized)
1.0 Submitter
Bio-Rad Laboratories 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1555
Contact Person
Yvette Lloyd Senior Regulatory Affairs Specialist Telephone: (949) 598-1465
Date of Summary Preparation
June 06, 2001
2.0 Device Identification
Product Trade Name: Abbott Tumor Marker - MCC (Lyophilized)
Common Name: Multi-Analyte Controls, (Assayed and unassayed)
Classifications: Class I Product Code: 75JJY Regulation Number: CFR 862.1660
3.0 Device to Which Substantial Equivalence is Claimed
Abbott Tumor Marker - MCC (Lyophilized) Bio-Rad Laboratories Irvine, California
Docket Number: K990610
4.0 Description of Device
Abbott Tumor Marker - MCC (Lyophilized) is prepared from human serum with added constituents of human origin and pure chemicals.
The control is provided in lyophilized form for increased stability
1
5.0 Statement of Intended Use
Abbott Tumor Marker - MCC (Lyophilized) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in this package insert.
6.0 Comparison of the new device with the Predicate Device
The new Abbott Tumor Marker – MCC (Lyophilized) claims substantial equivalence to the Abbott Tumor Marker -- MCC (Lyophilized) currently in commercial distribution (K990610). The new Abbott Tumor Marker - MCC (Lyophilized) contains all the analytes as the predicate device plus B2 Microglobulin and PAP. The new device has improved reconstituted freeze-thaw stability claims for PSA.
| Abbott | Abbott | |
|---|---|---|
| Characteristics | Tumor Marker - MCC (Lyophilized) | |
| (New Device) | Tumor Marker - MCC (Lyophilized) | |
| (Predicate Device) | ||
| Similarities | ||
| Intended Use | Tumor Marker - MCC | |
| (Lyophilized) is intended for use | ||
| as a quality control serum to | ||
| monitor the precision of laboratory | ||
| testing procedures for the | ||
| analytes listed in the package | ||
| insert. | Tumor Marker - MCC | |
| (Lyophilized) is intended for use as | ||
| a quality control serum to monitor | ||
| the precision of laboratory testing | ||
| procedures for the analytes listed | ||
| in the package insert. | ||
| Form | Lyophilized | Lyophilized |
| Matrix | Human serum based | Human serum based |
| Open | ||
| Vial Claim | All analytes will be stable for 14 | |
| days when stored at 2 – 8°C | ||
| tightly capped with the following | ||
| exceptions: Free PSA and PSA | ||
| should be assayed immediately | ||
| following reconstitution. | All analytes will be stable for 14 | |
| days when stored at 2 - 8°C tightly | ||
| capped with the following | ||
| exceptions: Free PSA and PSA | ||
| should be assayed immediately | ||
| following reconstitution. | ||
| Storage | ||
| (Unopened) | 2°C to 8°C | |
| until expiration date | 2°C to 8°C | |
| until expiration date |
Table 1. Similarities and Differences between new and predicate device.
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| Differences | ||
|---|---|---|
| Analytes | ||
| Claimed | All the same analytes as the | |
| current Abbott Tumor Marker - | ||
| MCC (Lyophilized), plus B2 | ||
| Microglobulin and PAP. | AFP, CA 15-3, CA 19-9, CA 125, | |
| CEA, Free PSA, PSA. | ||
| Reconstituted | ||
| Freeze Vial | ||
| Claim | All analytes will be stable after | |
| reconstituting and freezing for 30 | ||
| days when stored at -10°C to - | ||
| 20°C. | All analytes will be stable for 30 | |
| days after reconstituting and | ||
| freezing when stored at -10°C to - | ||
| 20°C, with the following | ||
| exceptions: (1) PSA will be stable | ||
| for 20 days. |
Table 1. Similarities and Differences between new and predicate device, continued.
7.0 Summary of Performance Data
Stability studies have been performed to determine the open vial stability and shelf life for the Abbott Tumor Marker - MCC (Lyophilized). Product claims are as follows:
- Once the control is reconstituted, all analytes will be stable for 14 days 7.1 when stored tightly capped at 2 - 8℃, with the following exceptions: Free PSA and PSA should be assayed immediately following reconstitution.
- After reconstituting and freezing the control, all analytes will be stable for 7.2 30 days when stored tightly capped at -10℃ to -20℃. Once thawed, do not refreeze the control; discard remaining material.
- The control is stable for 3 years and 3 months when stored unopened at 2 7.3 - 8℃.
Real time studies will be ongoing to support the shelf life of this product.
All supporting data is retained on file at Bio-Rad Laboratories.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." around the perimeter. Inside the circle is an emblem of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 1 7 2001
Ms. Donna Chapman Quality Assurance/Regulatory Affairs Manager Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
510(K) Number: K011853 Re: 510(11) Frade/Device Name: Abbott Tumor Marker - MCC (Lyophilized) Regulation Number: 862.1160 Regulatory Class: I Product Code: JJY Dated: June 6, 2001 Received: June 13, 2001
Dear Ms. Chapman:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your becally in the substantially equivalent (for the indications for use above and we nave determined the actives marketed predicate devices marketed in interstate commerce stated in the encrosure) to legally manetes of the Medical Device Amendments, or to devices that provity 20, 1970, are encounces with the provisions of the Federal Food, Drug, and Tiave been tectassified in accordance market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general controliberturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see associates and additional controls. Existing major regulations (Fremarks Approvary, it the Code of Federal Regulations, Title 21, Parts 800 to 895. affecting your do rios can determination assumes compliance with the Current Good A substantany equirements, as set forth in the Quality System Regulation (QS) for Manufacturing Fraction regulation (21 CFR Part 820) and that, through periodic QS Medical Devices. General regulation (FDA) will verify such assumptions. Failure to inspections, the Food and Drug result in regulatory action. In addition, FDA may publish comply with the GMT regaration in our device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might It spollse to your promations of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and in you to objak antial equivalence of your device to a legally marketed noutication. The I Drice results in 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 If you desire specific active for your atic devices), please contact the Office of Compliance at additionally 007.10 for mirring and stimment on the promotion and advertising of your device, (301) 591 1500: Traditionally, at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on your rooperation.oll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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):_ 竹O川8S3
Abbott Tumor Marker - MCC (Lyophilized) Device Name:
Indications for Use:
Abbott Tumor Marker – MCC (Lyophilized) is intended for use as an assayed Abbott Tamor Mariotr the precision of laboratory testing procedures for the analytes listed in the insert.
Jacket
(Division/Sign-Off) Division Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THE LINE-CONINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use or
Over-the Counter use