SICKLE-CHEX

K013316 · Streck Laboratories, Inc. · GHM · Nov 6, 2001 · Hematology

Device Facts

• Record ID: K013316
• Device Name: SICKLE-CHEX
• Applicant: Streck Laboratories, Inc.
• Product Code: GHM · Hematology
• Decision Date: Nov 6, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7825
• Device Class: Class 2

Indications for 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.

Device Story

Sickle-Chex is a quality control product for sickle cell hemoglobin testing. It consists of two vials: a positive control containing human red blood cells that test positive for hemoglobin S, and a negative control containing normal human red blood cells that test negative. The device is used in clinical laboratories to verify the performance of sickle cell solubility test reagents and hemoglobin electrophoresis systems. By providing known positive and negative samples, the device allows laboratory personnel to validate the accuracy and reliability of their diagnostic test kits, ensuring consistent results for patient screening.

Clinical Evidence

No clinical data; bench testing only. The device is a quality control material; performance is verified by its ability to produce expected positive and negative results using standard sickle cell hemoglobin solubility test reagents and electrophoresis methods.

Technological Characteristics

Consists of human red blood cells in a preservative suspension media. Packaged in 2.5 ml polyethylene dropper bottles with dispensing tips. Non-electronic, non-sterile, standalone control material.

Indications for Use

Indicated for use as a quality control material for verifying the performance of sickle cell hemoglobin solubility test kits and hemoglobin electrophoresis methods. Intended for professional clinical laboratory use.

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.

Submission Summary (Full Text)

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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

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.

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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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, [phone]. I reading of Compliance at [phone]. 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 [phone] 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) ✓

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