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.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the Sickle-Chex 510(k) notification, focusing on the acceptance criteria and the study that proves the device meets them:

Disclaimer: This device is a quality control material, not a diagnostic device for direct patient use. Therefore, the "acceptance criteria" and "study" described are about the performance of the control material itself in verifying diagnostic tests, rather than its diagnostic accuracy on patient samples. Many of the questions provided in the prompt are more applicable to diagnostic devices, and the information in the 510(k) for a control material will naturally be different.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Positive Control Performance	"Will produce a positive test for sickling hemoglobin using standard sickle cell hemoglobin solubility test reagents."	The submission implies that the Positive Control meets this by its intended use description. No specific numerical data on its "positivity rate" or "consistency" across multiple tests/labs is directly provided in the accessible text. It functions as a known positive.
Negative Control Performance	"Will produce a negative test for sickling hemoglobin using standard sickle cell hemoglobin solubility test reagents."	The submission implies that the Negative Control meets this by its intended use description. No specific numerical data on its "negativity rate" or "consistency" is directly provided in the accessible text. It functions as a known negative.
Hemoglobin Electrophoresis Use	"May also be used as a control in hemoglobin electrophoresis methods."	The submission states this as an intended use. No specific performance data for this application is provided in the accessible text, but its utility as a control assumes it exhibits predictable electrophoretic properties for hemoglobin S (in the positive control) and normal hemoglobin (in the negative control).
Stability (Implied)	Maintain performance over its stated shelf life.	Not explicitly stated in the provided text, but essential for any control material. The fact it's "Assayed Sickle Cell Control" suggests its characteristics are measured and stable.
Matrix Compatibility (Implied)	Compatible with standard sickle cell hemoglobin solubility test reagents and electrophoresis methods.	Implied by the intended use.

Study Proving Acceptance Criteria:

The provided text does not contain a detailed study section with explicit methodology, results, or statistical analysis to "prove" the device meets acceptance criteria in the way a diagnostic device would.

Instead, for a quality control material like Sickle-Chex, the "proof" primarily relies on:

Manufacturing and Characterization: The control material is manufactured to contain human red blood cells with specific hemoglobin characteristics (presence of Hb S in the positive control, absence in the negative control).
Intended Use Statements: The submission defines the intended use, which inherently outlines the expected performance: "The Positive Control will produce a positive test..." and "The Negative Control contains normal human red blood cells that will produce a negative test...". This is a statement of what the product is designed to do and what has been verified during its development.
Substantial Equivalence: The FDA's 510(k) clearance is based on a determination of substantial equivalence to a predicate device. This means that the FDA found the Sickle-Chex to be as safe and effective as a legally marketed predicate device, likely by demonstrating similar performance characteristics through internal testing and possibly comparison to the predicate. The document refers to "Predicate product package insert and assay sheet," suggesting that the performance of Sickle-Chex was benchmarked against an existing similar product.

Without access to the full 510(k) submission, specific details of laboratory characterization and comparison to the predicate device are not available in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified in the provided text. For a control material, the "test set" would likely refer to a series of internal characterization tests and comparisons to a predicate device.
Data Provenance: Not specified. It can be inferred that any testing would have been conducted by Streck Laboratories, Inc. (USA) as part of their manufacturing and regulatory submission process.
Retrospective or Prospective: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This concept of "experts establishing ground truth" is generally not applicable to the characterization of a quality control material. The "ground truth" for Sickle-Chex is inherent in its design and manufacturing:

The Positive Control is designed to contain sickling hemoglobin (Hb S).
The Negative Control is designed to contain normal hemoglobin.
The presence or absence of Hb S would be determined through standard laboratory methods (e.g., electrophoresis, high-performance liquid chromatography, or other definitive assays) during the manufacturing and quality control process, not by expert consensus in the same way a diagnostic image might be interpreted.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/not specified. Adjudication methods are typically used for interpreting subjective data (like imaging) from multiple human readers. For the characterization of a chemical/biological control, objective laboratory measurements are used, not human reader adjudication.

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

Not applicable. Sickle-Chex is a quality control material, not an AI diagnostic device. An MRMC study would not be performed for this product.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. Sickle-Chex is a physical control material, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the Sickle-Chex controls is their inherent biochemical composition.

The Positive Control contains human red blood cells with hemoglobin S. This is confirmed through definitive laboratory assays during its production.
The Negative Control contains human red blood cells with normal hemoglobin. This is also confirmed through definitive laboratory assays.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is not an AI/machine learning device.

Summary

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K013316

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

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.

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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.

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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

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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) ✓

Over-The-Counter Use

(Optional Format 1-2-96)

Date:

Sunshine Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K013316

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).