(61 days)
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No
The device description and performance studies indicate a chemical-based solubility test kit, with no mention of AI or ML technologies.
No
The Sickle-Chex Solubility Kit is a qualitative diagnostic test kit used to detect the presence of sickling hemoglobins; it is not used to treat, cure, mitigate, or prevent disease.
Yes
This device is a qualitative solubility test kit for detecting sickling hemoglobins, which is used to identify a medical condition (sickle cell disease), making it a diagnostic device.
No
The device description clearly outlines physical components (buffer solution in bottles, reagent powder in vials) which are hardware, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "testing the presence of sickling hemoglobins in human blood or sickle cell control material." This involves testing a sample taken from the human body (blood) in vitro (outside the body).
- Device Description: The description details the components of a test kit designed to perform this analysis on the blood sample.
- Testing Principles: It mentions being based on NCCLS, H10-F, which are standards related to laboratory testing procedures.
These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.
Product codes (comma separated list FDA assigned to the subject device)
GHM
Device Description
Sickle-Chex Solubility Kit consists of:
- Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin.
- Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite.
The testing principles of the kit is based on NCCLS, H10-F.
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)
In house studies were: Closed Vial Long Term studies on the Solubility Buffer and Reagent Powder, and Open Vial Studies on the working solution. Off-site studies were conducted to verify the performance of theck's Sickle-Chex Solubility Kit verses competitor(s) solubility kits.
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
DEC 3 0 2002
510(k) Summary of Safety and Effectiveness
| 510(k) Submitter: | Streck Laboratories
7002 South 109th Street
La Vista, NE 68128 |
| ------------------- | ---------------------------------------------------------------------- |
|---|
Official Correspondent: Carol Thompson, Quality Assurance Manager (402) 537-5313
December 13, 2002 Date Prepared:
Names of Device:
| Trade Name: | Sickle-Chex Solubility Kit |
|---|---|
| Common Name: | Sickle Cell Test |
| Classification Name: | Sickle Cell Test, 21CFR864.7825 |
DADE Behring Inc., Dade® Sickle-Sol™Test. Predicate Device:
Description:
Sickle-Chex Solubility Kit consists of:
- Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin.
- Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite.
The testing principles of the kit is based on NCCLS, H10-F.
Intended Use:
Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.
Comparison with Predicate Device:
Sickle-Chex Solubility Kit and Sickle-Sol™Test are similar and have the same intended application.
Sickle-Chex Solubility Kit adds the Saponin to the Phosphate buffer, where as Sickle-Sol Test adds to Saponin to the reagent powder.
Sickle-Chex Solubility Kit has 45 day open vial dating for the werking solubility buffer, where as the Sickle-Sol Test has 30 day open vial dating for its working solubility solution.
Testing Performed:
In house studies were: Closed Vial Long Term studies on the Solubility Buffer and Reagent Powder, and Open Vial Studies on the working solution. Off-site studies were conducted to verify the performance of theck's Sickle-Chex Solubility Kit verses competitor(s) solubility kits.
Conclusions Drawn from the Tests:
Sickle-Chex Solubility Kit will perform satisfactorily as a qualitative solubility test kit for testing for the presence of sickling hemoglobins in numan blood or sickle cell control material. Laboratories can be assured of correct results over the shelf life of the product.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a simple, black line drawing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
ood and Drug Administration 98 Gaither Road ockville MD 20850
Ms. Kerrie Oetter Ouality Assurance Coordinator/ Regulatory Affairs Streck Laboratories, Inc. 8 7002 South 109th Street LaVista, NE 68128
K023656 Re:
Trade/Device Name: Sickle-Chex Solubility Kit Regulation Number: 21 CFR 864.7825 Regulation Name: SickleTest System Regulatory Class: Class II Product Code: GHM Dated: October 28, 2002 Received: October 30, 2002
Dear Ms. Oetter:
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. Ilsting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 –
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.
If you desire specific information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
510(k) Number:
Device Name:
Indications For Use:
Sickle-Chex Solubility Kit is a qualitative sclubility təst kit for testing the presence of sickling hemoglobins in human blood or sickle cell control material.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Sickle-Chex Solubility Kit
Concurrence of CDRH, Office of Device Evaluation 'OlD
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use -
(Optional Formal 1-2-96)
Date:
Josephine Rantaki
(Division Sign-Off)
n of Clinical Laboratory Devices
510(k) Number K023656