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K Number
K955719
Device Name
SICKLE-2000
Manufacturer
MEDICUS TECHNOLOGIES, INC.
Date Cleared
1996-08-14

(240 days)

Product Code
GIQ
Regulation Number
864.7415
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 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.
More Information

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No
The description focuses on a centrifugal solubility test and does not mention any AI/ML components or image processing.

No
The device is an in-vitro diagnostic test used to detect Hemoglobin S, which is related to diagnosis rather than treatment of a disease or condition.

Yes

The device detects Hemoglobin S, which is an abnormal hemoglobin found in sickle cell disease and sickle cell trait, and is used to identify these conditions, thus serving a diagnostic purpose.

No

The device description explicitly states it is an "in-vitro centrifugal solubility test," which implies the use of physical reagents, tubes, and a centrifuge, indicating it is a hardware-based diagnostic test, not software-only.

Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use/Indications for Use: The statement "SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S..." explicitly states that the test is performed "in-vitro" (outside of the body) and is used for diagnostic purposes (detecting Hemoglobin S, which is indicative of sickle cell disease and trait).
  • Device Description: The description reiterates the in-vitro nature of the test and its purpose of detecting Hemoglobin S.

These points clearly align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes.

N/A

Intended Use / Indications for Use

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Product codes

21 CFR 864.7825

Device 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.

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

The clinical performance of this test was determined in two different studies.

  1. 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.
  2. 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.

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.

  • 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.
  • Real time stability studies indicate the product is good for at least 12 months.
  • 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.
  • The potential interfering effects of lipemia, bilirubin and hemolysis were studied. There is no triglyceride interference up 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. With heterozygous(AS) blood there is no interference up to 15mg/dl bilirubin.

Key Metrics

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Predicate Device(s)

Sicklequik (Organon Teknika, Durham,NC)

Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 864.7415 Abnormal hemoglobin assay.

(a)
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.(b)
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.

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AUG 1 4 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 prformance 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.

  1. 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

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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.

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