(52 days)
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.
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.
Here's an analysis of the provided text regarding the R&D Sickle QC Hematology Control, presented according to your requested format:
Acceptance Criteria and Device Performance Study for R&D Sickle QC Hematology Control
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Remain within assay range over the life of the product | "R&D Sickle QC Hematology Control passed the acceptance criteria of remaining within the assay range over the life of the product." |
| Demonstrate precision | "R&D Sickle QC Hematology Control has demonstrated precision as indicated by the small standard deviation obtained during laboratory testing." |
| Established expiration dating | 6 months (closed vial) and 100 days (open vial) when stored at 2 - 8° C and handled according to instructions for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "3 validation lots" were used for testing. The specific number of individual samples within these lots is not provided.
- Data Provenance: The data appears to be prospective as it describes "laboratory testing" that was conducted to validate the product. The country of origin is implicitly the United States, as the submission is to the U.S. FDA by R&D Systems, Inc., based in Minneapolis, MN.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the given text. The "ground truth" for the performance metrics (assay range, precision) would likely be established by the product specifications and analytical methods of the lab conducting the validation, rather than expert consensus on diagnostic images or clinical outcomes.
4. Adjudication Method for the Test Set
- This information is not applicable and therefore not provided in the text. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert review of diagnostic cases where there might be disagreement (e.g., in medical image analysis). This is a laboratory control product, and its performance is evaluated against predefined analytical metrics.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools that impact human interpretation of cases. The R&D Sickle QC Hematology Control is a laboratory control material, not a diagnostic device that humans interpret in conjunction with AI.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
- Yes, a form of standalone performance evaluation was done. The "laboratory testing of 3 validation lots" directly assessed the performance characteristics (precision, stability within range) of the Sickle QC product itself, independent of human interpretation or assistance. It's important to note this isn't an "algorithm" in the typical AI sense, but rather the performance of the control material in a laboratory setting.
7. The Type of Ground Truth Used
- The ground truth for this device's performance is established by analytical specifications and established laboratory methods/standards. For example, the "assay range" would be a pre-defined range within which the control is expected to perform, and "precision" would be measured against statistical benchmarks for variability. It is not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- This information is not applicable and therefore not provided. The R&D Sickle QC Hematology Control is a physical control material, not an AI/machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for this type of device.
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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.
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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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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
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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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-CounterUse
(Optional Format 1-2-96)
Josephine Bautist
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K670334
§ 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.