SICKLE-2000

K955719 · Medicus Technologies, Inc. · GIQ · Aug 14, 1996 · Hematology

Device Facts

• Record ID: K955719
• Device Name: SICKLE-2000
• Applicant: Medicus Technologies, Inc.
• Product Code: GIQ · Hematology
• Decision Date: Aug 14, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7415
• Device Class: Class 2

Indications for Use

SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.

Device Story

SICKLE-2000 is an in-vitro centrifugal solubility test for detecting Hemoglobin S. The device utilizes a reagent containing mineral oil to facilitate the solubility test. It is used in clinical laboratory settings to identify sickle cell disease and sickle cell trait. The test involves adding blood samples to test tubes containing the reagent; the centrifugal process allows for the visual identification of Hemoglobin S. Results are interpreted by laboratory personnel to assist in the diagnosis of hemoglobinopathies. The device provides a rapid screening method for patient assessment.

Clinical Evidence

Two studies conducted. Study 1: Comparison with Sicklequik (n=87; 66 normal, 15 heterozygous AS, 6 homozygous SS); 100% concordance. Study 2: Blinded study vs. hemoglobin electrophoresis (n=99; 59 normal, 40 heterozygous AS); 100% correct identification. Additional bench testing included accelerated aging (Arrhenius plotting), real-time stability (12 months), limit of detection (2.0g/dl HbS), and interference testing (lipemia, hemolysis, bilirubin).

Technological Characteristics

In-vitro centrifugal solubility test. Reagent contains sodium bisulfite, saponin, and mineral oil. Detects Hemoglobin S at concentrations down to 2.0g/dl. Stable for at least 12 months. No interference from triglycerides up to 1000mg/dl or hemolysis. Bilirubin interference thresholds vary by hemoglobin genotype (up to 60mg/dl for AA/SS; up to 15mg/dl for AS).

Indications for Use

Indicated for the detection of Hemoglobin S in human blood samples to identify sickle cell disease and sickle cell trait.

Regulatory Classification

Identification

An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

Special Controls

*Classification.* Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Sicklequik (Organon Teknika)

Submission Summary (Full Text)

{0}

AUG 14 1996
K955719

# 510(K) SUMMARY for SICKLE-2000

Submitted by: Medicus Technologies, Inc.
515 S. Franklin St.
West Chester, PA 19382
Telephone # is 610-692-5711
Fax # is 610-692-1913
Registration # 2518629

1. Product name: The trade name is SICKLE-2000. The common name is Sickle cell test or Sickle cell Hb solubility test.

2. This is a class II device (21 CFR 864.7825, Sickle cell test).

3. Description: SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.

4. Product equivalency: The predicate device most like SICKLE-2000 is Sicklequik (Organon Teknika, Durham, NC). The only difference is that mineral oil is a component of the SICKLE-2000 reagent and toluene is a component of the Sicklequik reagent. Sicklequik is a pre-amendment device.

5. The clinical performance of this test was determined in two different studies. One study compared SICKLE-2000 to Sicklequik. Blood samples were added to both Sicklequik and SICKLE-2000 tubes and the results compared. Eighty seven patients were tested. 66 contained no hemoglobin S. 15 were heterozygous (AS), and 6 homozygous (SS). In each instance the results were the same.

In a blind study 59 normal samples and 40 heterozygous S samples that had previously been tested by hemoglobin electrophoresis were tested by SICKLE-2000. SICKLE-2000 correctly identified each sample.

6. Additional studies conducted include accelerated aging, real time stability, the determination of the lowest concentration of hemoglobin S that can be detected, and potential interfering substances.

6.1 Accelerated aging was done on three batches, each made with a different lot of mineral oil. Arrhenius plotting indicated no significant change in sodium bisulfite or saponin activity over a two year time period.

6.2 Real time stability studies indicate the product is good for at least 12 months. Expiration dating will be based on real time stability studies.

6.3 The lowest concentration of hemoglobin S that can be detected was determined using 10 heterozygous S samples. This concentration is 2.0g/dl hemoglobin S.

6.4 The potential interfering effects of lipemia, bilirubin and hemolysis were studied. There is no triglyceride interference up

{1}

6

to 1000mg/dl. Hemolysis does not interfere. With normal(AA) blood there is no interference up to 60mg/dl bilirubin. With homozygous(SS) blood there is no interference up to 60mg/dl bilirubin. The lower aqueous phase which is normally yellow, simply gets more yellow with additional bilirubin. With heterozygous(AS) blood there is no interference up to 15mg/dl bilirubin. At 30 mg/dl bilirubin the aqueous phase has an orange and slightly darker appearance. At 60mg/dl bilirubin it is more orange and darker.

7. The conclusion drawn from the above studies is that the device is safe, effective, and performs as well as the predicate device Sicklequik.