SICKLE-CHEX SOLUBILITY KIT

K023656 · Streck Laboratories, Inc. · GHM · Dec 30, 2002 · Hematology

Device Facts

• Record ID: K023656
• Device Name: SICKLE-CHEX SOLUBILITY KIT
• Applicant: Streck Laboratories, Inc.
• Product Code: GHM · Hematology
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7825
• Device Class: Class 2

Indications for Use

Sickle-Chex Solubility Kit is a qualitative solubility test kit for testing the presence of sickling hemoglobins in human blood or sickle cell control material.

Device Story

Sickle-Chex Solubility Kit is a qualitative in vitro diagnostic test for sickling hemoglobins. The kit comprises a 2.3M potassium phosphate buffer solution containing Saponin and a separate reagent powder containing Sodium Hydrosulfite. The test follows NCCLS H10-F principles. The user mixes the buffer and reagent to create a working solution, which is then combined with a blood sample. The presence of sickling hemoglobins is determined by visual observation of the solution's turbidity. The device is intended for use in clinical laboratory settings by trained personnel. It provides a qualitative result to assist in the identification of hemoglobin S, aiding in the diagnosis or screening of sickle cell disease.

Clinical Evidence

Bench testing only. Studies included closed-vial long-term stability testing for the buffer and reagent powder, and open-vial stability testing for the working solution. Off-site performance verification was conducted comparing the Sickle-Chex Solubility Kit against competitor solubility kits to confirm qualitative accuracy.

Technological Characteristics

Qualitative solubility test kit. Components: 2.3M potassium phosphate buffer, Saponin, Sodium Hydrosulfite. Form factor: Liquid buffer in LDPE bottles, reagent powder in glass vials. Principle: NCCLS H10-F solubility test. No software or electronic components.

Indications for Use

Indicated for the qualitative detection of sickling hemoglobins in human blood or sickle cell control material.

Regulatory Classification

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.

Predicate Devices

• DADE Behring Inc., Dade® Sickle-Sol™Test

Submission Summary (Full Text)

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K023656

DEC 3 0 2002

# 510(k) Summary of Safety and Effectiveness

| 510(k) Submitter: | Streck Laboratories<br>7002 South 109th Street<br>La Vista, NE 68128 |
|-------------------|----------------------------------------------------------------------|
|-------------------|----------------------------------------------------------------------|

Official Correspondent: Carol Thompson, Quality Assurance Manager [phone]

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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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 [phone]. 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 [phone] or [phone] 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)
✓

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