(33 days)
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Not Found
No
The summary describes a control material for laboratory tests, not a device that processes data or images using AI/ML.
No
The device is described as a control material used in testing for sickle cell hemoglobin, not for treating any condition.
No
Explanation: The device is described as a "sickle cell control" intended for "verifying performance of sickle cell hemoglobin testing systems." It is used to check the accuracy of other tests, not to diagnose a condition in a patient directly.
No
The device description explicitly states it consists of "human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle," indicating it is a physical control material, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis." These are laboratory tests performed in vitro (outside the body) on biological samples (human red blood cells).
- Device Description: The device consists of "Control materials for verifying performance of sickle cell hemoglobin testing systems." Control materials used in laboratory testing are a common type of IVD.
- Components: It contains "human red blood cells and preservative suspension media," which are biological components used in in vitro testing.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Sickle-Chex fits this description as it's used to verify the performance of tests that diagnose sickle cell disease.
N/A
Intended Use / Indications for Use
Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.
Product codes (comma separated list FDA assigned to the subject device)
GHM
Device Description
Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.
Mentions image processing
Not Found
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.
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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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§ 864.7825 Sickle cell test.
(a)
Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.(b)
Classification. Class II (performance standards).
0
October 2, 2001
Sickle-Chex 510(k) Notification
Names
Trade Name Common Name: Classification Name: Classification Number:
Sickle-Chex Assayed Sickle Cell Control Sickle Cell Test, 21 CFR 864.7825 Not Available
Establishment Registration Number
1950302
Classification
FDA has assigned Sickle Cell Test to Class II. performance standards.
Actions Taken to Comply with FDCA Section 154
No government mandatory or industry voluntary performance standards exist for this type of device.
Representative Labels and Labeling
Proposed vial labels and other labeling attached:
a. Package insert/ assay sheet
b. Vial labels (Table I)
- c. Outer package labeling (Table I)
Predicate product package insert and assay sheet
Physical description of Device
Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.
Intended Use
Sickle-Chex consists of two controls. The Positive Control is a suspension of human red blood cells in a preservative media. This product is intended for use as a quality control material for sickling hemoglobin test kits. The Positive Control will produce a positive test for sickling hemoglobin using standard sickle cell hemoglobin solubility test reagents. In like manner, the Negative Control contains normal human red blood cells that will produce a negative test for sickling hemoglobin using standard sickle cell hemoglobin solubility test reagents.
Sickle-Chex may also be used as a control in hemoglobin electrophoresis methods.
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three heads, representing the department's focus on health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Paul Kittelson Ouality Assurance/Regulatory Affairs Streck Laboratories, Ins.® 7002 South 109th Street LaVista, NE 68128
NOV 0 6 2001
Re: K013316 Trade/Device Name: Sickle-Chex Regulation Number: 21 CFR 864.7825 Regulation Name: Sickle cell test Regulatory Class: Class II Product Code: GHM Dated: October 3, 2001 Received: October 4, 2001
Dear Mr. Kittelson:
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.
2
Page 2 -
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 nouthoution. 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 1 If you desire specific actives diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (201) 591-1500. I reading of Compliance 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 mionimation on your responsibility on sumer Assistance at its toll-free number (800) 638-2041 or 1301) 443-6597 or at its internet address "http://www.fda.gov/odrh/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
3
NOV 0 6 2001
Ko 133/6
Page 1_of _ 1_
510(k) Number:
K01 33/6
Sickle-Chex
Device Name:
Indications For Use:
Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Date:
Sunshine Bautista
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K013316