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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Sickle-Chex Solubility Kit, with an emphasis on the acceptance criteria and supporting study details.

Important Note: The provided document is a 510(k) summary, which is a regulatory document filed to demonstrate substantial equivalence to a predicate device. It typically summarizes studies and conclusions without going into granular detail on study designs, statistical methodologies, or all acceptance criteria. Therefore, some specific details requested (like exact sample sizes for test/training sets, blinding protocols, or multi-reader studies) are not explicitly stated in this document.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the Sickle-Chex Solubility Kit primarily focuses on demonstrating equivalence to a predicate device (Dade® Sickle-Sol™ Test) and confirming the product's stability and reliability. The acceptance criteria, while not explicitly listed as quantitative metrics in a table, can be inferred from the "Conclusions Drawn from the Tests."

Acceptance Criteria (Inferred)	Reported Device Performance
Functional Equivalence: Device performs satisfactorily as a qualitative solubility test for sickling hemoglobins.	"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." This performance was verified through "Off-site studies... to verify the performance ofck's Sickle-Chex Solubility Kit verses competitor(s) solubility kits." This implies the performance was comparable to or met expectations relative to predicate/competitor devices.
Stability - Closed Vial: Long-term stability of Solubility Buffer and Reagent Powder.	"Closed Vial Long Term studies on the Solubility Buffer and Reagent Powder" were performed. The conclusion states: "Laboratories can be assured of correct results over the shelf life of the product." This indicates the closed-vial components maintain their integrity and performance.
Stability - Open Vial: Stability of the working solubility buffer once opened.	"Open Vial Studies on the working solution" were conducted. The device has a "45 day open vial dating for the working solubility buffer," which is an improvement over the predicate device (30 days). The overall conclusion regarding assured correct results over shelf life also applies to this aspect.
Qualitative Output: Ability to correctly identify positive/negative for sickling hemoglobins.	The device is designed as a "qualitative solubility test kit." The successful performance verification implies it correctly provides qualitative results. Specific sensitivity/specificity metrics were not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated in the 510(k) summary. The document mentions "Off-site studies" and "in house studies," but does not provide the number of samples or cases used in these evaluations.
Data Provenance:
- Country of Origin: Not explicitly stated. Given that Streck Laboratories is located in La Vista, NE (USA) and the regulatory body is the FDA (USA), it is highly probable the data was collected within the USA.
- Retrospective or Prospective: Not explicitly stated. "Off-site studies" could be either, but often includes prospective testing in a laboratory setting. "In house studies" would also typically be prospective testing conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Number of Experts: Not mentioned. This type of qualitative solubility test typically relies on direct chemical reaction observation, and the "ground truth" for evaluating the kit's performance would likely be established by comparing its qualitative results against established laboratory methods or reference materials.
Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not mentioned. For a chemical solubility test, the "adjudication method" involving human experts reading results is usually not relevant in the same way it would be for image-based diagnostics. The ground truth for such a test is typically based on the chemical principle itself, or comparison to established reference methods/materials.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a qualitative chemical test kit.
Effect Size of AI Improvement: Not applicable, as no MRMC study was conducted and this is not an AI-assisted device.

6. Standalone Performance Study

Standalone Performance Study: Yes, a standalone performance evaluation was implicitly done. The "Off-site studies" that verified the performance against competitor kits, and the "in house" stability studies, represent the device's performance characteristics independent of human interpretation beyond recording the qualitative reaction. The device itself is the "algorithm" in this context, producing a qualitative result.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this type of device would typically be:
- Reference Method Comparison: Comparing the results of the Sickle-Chex kit to a gold-standard or well-established method for detecting sickling hemoglobins (e.g., electrophoresis, or another validated solubility test).
- Known Samples: Testing with control materials or patient samples with known sickle cell status (e.g., confirmed by genetic testing or other definitive methods).
- Clinical Outcomes Data: Unlikely to be the primary ground truth for a qualitative screening test.
- Expert Consensus: Unlikely to be the primary ground truth for a chemical reaction test.

The summary mentions "sickle cell control material" and "human blood," suggesting a combination of known samples and potentially clinical samples verified by other means.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable / not mentioned. This device is a chemical reagent kit, not an AI/ML algorithm that requires a distinct "training set" in the computational sense. Its performance is based on its chemical formulation and reaction properties.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth for such a set in the context of machine learning. The chemical properties and formulation are developed and refined through R&D and quality control, not via a machine learning training process.

Summary

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K023656

DEC 3 0 2002

510(k) Summary of Safety and Effectiveness

510(k) Submitter:	Streck Laboratories7002 South 109th StreetLa 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.

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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

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510(k) Number:

K023656

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)
✓

Over-The-Counter Use -

(Optional Formal 1-2-96)

Date:

Josephine Rantaki
(Division Sign-Off)

n of Clinical Laboratory Devices

510(k) Number K023656

Regulation Number and Section

§ 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).