(39 days)
R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.
R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.
The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.
The provided document is a 510(k) summary for the R&D Glucose/Hemoglobin™ Whole Blood Control, a device used for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin. As such, it is a control solution used to validate other medical devices, not a diagnostic or prognostic device that itself interprets patient data. Therefore, many of the typical acceptance criteria and study components requested in the prompt, which are usually applicable to diagnostic algorithms or medical imaging devices (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details), are not relevant or present in this context.
However, based on the information available, here's a summary tailored to the nature of this device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remaining within the assay range over the life of the product | Met: Stability established for 205 days (closed vial) and 30 days (open vial) when stored at 2-8°C. Met: Open vial stability of 7 days at ambient temperature. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the traditional sense for a control solution. The "test set" here refers to the actual R&D Glucose/Hemoglobin™ Whole Blood Control product itself, which was tested for its performance attributes.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective for a control solution's performance testing. The testing was conducted by R&D Systems, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth for a control solution isn't established by expert consensus on patient data. Instead, the "truth" is its assayed value, which would be determined through validated laboratory methods and measurements against reference standards, not expert interpretation.
4. Adjudication method for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among human reviewers of patient data, which is not relevant for a control solution.
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 device is a control solution, not an AI-powered diagnostic tool, and therefore MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a biochemical control solution, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device is its assayed value for glucose and hemoglobin, which is intrinsically determined during its manufacture and verified through laboratory testing. This is analogous to a certified reference material, where the "truth" is established by its chemical composition and precise measurements, not by expert consensus, pathology, or outcomes data in the clinical diagnostic sense.
8. The sample size for the training set
- Not applicable. This device is a control solution, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
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NOV I 2 1999
Image /page/0/Picture/1 description: The image shows a logo with the letters 'R' and '&' stacked on top of the letter 'D'. The letters are in a bold, sans-serif font and are black. Below the letters, there is some text that is blurry and difficult to read. The logo appears to be for a company or organization, but the specific name is not clear.
510(k) Summary R&D Glucose/Hemoglobin™ Whole Blood Control
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K993321.
Date of Summary: Company Name:
September 30, 1999 R&D Systems, Inc. 614 McKinley Place N.E. Minneapolis, MN 55413 Kenneth T. Edds, Ph.D. 612-379-2956, FAX 612-379-6580
Contact name:
Classification name: Product name:
ਜਦਾ
R&D Glucose/Hemoglobin™ Whole Blood Control
CFR section: Device Class:
Class II
Device to which substantial equivalence is claimed: HO-Chex, manufactured by Streck Laboratories, Omaha, NE. 510(k) number: K961195
Intended use: R&D Glucose/Hemoglobin™ Whole Blood Control is an assayed whole blood product for monitoring the accuracy and precision of analyzers that measure glucose and hemoglobin in whole blood.
The product is composed of human erythrocytes and glucose in a plasma-like fluid with preservatives.
R&D Glucose/Hemoglobin™ Whole Blood Control has an intended use that is similar to the predicate device. The technology of the two devices is similar.
Nonclinical testing centered on the performance attributes of stability and precision. R&D Glucose/Hemoglobin™Whole Blood Control passed the acceptance criteria of remaining within the assay range over the life of the product. Expiration dating has been established at 205 days closed vial and 30 open vial when stored at 2-8°C and handled according to instructions for use. Vials kept at ambient temperature have an open vial stability of 7 days.
PHONE: (612) 379-2956 FAX: (612) 379-6580
WATS: (800) 343-7475 E-MAIL: info@rndsystems.com
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NOV 1 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Regulatory Affairs Manager R & D Systems, Inc. 614 McKinley Place N.E. Minneapolis, Minnesota 55413
Re: K993321 Trade Name: R & D Glucose/Hemoglobin™ Whole Blood Control Product Code: GGM Regulatory Class: II JJY I Dated: October 1, 1999 Received: October 4, 1999
Dear Dr. Edds:
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 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). 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 (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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulatory 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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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K993321 510(k) Number:
Device Name:R&D Glu/Hgb Control)
Indications for Use: R&D Glu/Hgb Control is an assayed whole blood product used to monitor the precision and accuracy of analyzers that measure glucose and hemoglobin in whole blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Peter E. Maher
(Division Sign-Off)
Division of Clinical Laboratory Devices K993321
510(k) Number
Prescription Use √
OR
Over-The-CounterUse
(Optional Format 1-2-96)
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.