(52 days)
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No
The document describes a hematology control solution for sickle cell testing and does not mention any AI or ML components or functionalities.
No.
The device is a control used in diagnostic testing for Hemoglobin S, not a device intended to treat or prevent a disease.
No
This device is a control material used for testing, not a device that directly diagnoses a patient's condition.
No
The device description clearly states it contains human red blood cells and is a control for solubility tests, indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "testing for the presence of Hemoglobin S in solubility tests." This is a diagnostic test performed in vitro (outside the body) on a biological sample (human red blood cells).
- Device Description: It's described as a "control for solubility tests used to detect Hemoglobin S." Controls are essential components in diagnostic testing to ensure the accuracy and reliability of the results.
- Nature of the Sample: The control contains "human red blood cells," which are a biological specimen used in diagnostic testing.
The device is designed to be used in vitro to evaluate the performance of a diagnostic test (solubility test for Hemoglobin S). This directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
Product codes
GGM
Device Description
Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits.
The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.
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)
Laboratory testing of 3 validation lots has shown R&D Sickle OC Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. R&D Sickle QC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D Sickle QC Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. Expiration dating has been established at 6 months (closed vial) and 100 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
K
MAR 2 9 2007
510(k) Summary R&D Systems, Inc. Sickle QC Hematology Control
| Date of Summary: | February 2, 2007 |
|---|---|
| Company Name: | R&D Systems, Inc. |
| 614 McKinley Place N.E. | |
| Minneapolis, MN 55413 | |
| Contact name: | Ralph E. Hogancamp |
| 612-656-4413, FAX 612-379-6809 | |
| Classification name: | Sickle Cell Test |
Product name: R&D Sickle QC Hematology Control CFR section: 21 CFR 864.7825 Sickle Cell Test Device Class: Class II
Predicate Device: Streck Sickle-Chex, K013316, November 06, 2001, Streck Laboratories, Inc., 7002 South 109th Street, LaVista, NE 68128.
Description: Sickle QC is a control for solubility tests used to detect Hemoglobin S. Sickle QC is compatible with other manufacturer's solubility kits.
The control contains human red blood cells that are processed and are suspended in an anti-microbial solution that completes the simulation of fresh whole blood.
Intended use: R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
Comparison: Both products are used as sickle cell controls in testing for Hemoglobin S in solubility tests. .
Discussion: Laboratory testing of 3 validation lots has shown R&D Sickle OC Hematology Control to have substantial equivalence in performance, precision and stability to the predicate device. R&D Sickle QC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product. R&D Sickle QC Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing. Expiration dating has been established at 6 months (closed vial) and 100 days (open vial) when stored at 2 - 8° C and handled according to instructions for use.
Conclusion: R&D Sickle QC Hematology Control is a safe and effective control for the above intended use when used as instructed in the package insert.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
R & D SYSTEMS, INC. 614 McKinley Pl., N.E. Minneapolis, MN 55413 Attn: Ralph E. Hogancamp
Re: K070334
Trade/Device Name: Regulation Number: 21 CFR 864.7825 Regulation Name: Hematology Quality Control Material Regulatory Class: Class II Product Code: GGM Dated: February 02, 2007 Received: February 26, 2007
MAR 2 9 2007
Dear Mr. Hogancamp:
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 have been reclassified 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 Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination 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 systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
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Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., MD, PhD
Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
KO 70334
Device Name: R&D Sickle QC Hematology Control
Indications for Use:
R&D Sickle QC Hematology Control is intended to be used as a sickle cell control in testing for the presence of Hemoglobin S in solubility tests.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-CounterUse
(Optional Format 1-2-96)
Josephine Bautist
Division Sign-Off
X
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K670334