(240 days)
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.
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.
Acceptance Criteria and Device Performance Study for SICKLE-2000
This document outlines the acceptance criteria for the SICKLE-2000 device and details the studies conducted to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided information, the acceptance criteria are implicitly derived from the comparative and blind studies, focusing on accurate identification of Hemoglobin S.
| Acceptance Criteria Category | Specific Criteria | SICKLE-2000 Device Performance |
|---|---|---|
| Clinical Performance (Accuracy) | Correctly identify samples with and without Hemoglobin S (Hb S). | - In comparison study with Sicklequik (N=87), results were identical for 66 non-Hb S, 15 heterozygous (AS), and 6 homozygous (SS) samples. - In blind study (N=99), correctly identified all 59 normal samples and all 40 heterozygous S samples. |
| Detection Limit | Detect Hemoglobin S at clinically relevant concentrations. | Detected Hemoglobin S at a concentration of 2.0g/dl using 10 heterozygous S samples. |
| Interference | No significant interference from common blood components (lipemia, bilirubin, hemolysis). | - No triglyceride interference up to 1000mg/dl. - Hemolysis does not interfere. - Bilirubin interference: - Normal (AA) blood: No interference up to 60mg/dl. - Homozygous (SS) blood: No interference up to 60mg/dl. - Heterozygous (AS) blood: No interference up to 15mg/dl. At 30 mg/dl and 60 mg/dl, the aqueous phase shows color changes (orange/darker) but implied non-interference to result. |
| Stability | Maintain performance over a specified shelf life. | - Accelerated aging indicated no significant change in activity over a two-year period. - Real-time stability studies indicated product is good for at least 12 months. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set 1 (Comparison Study):
- Sample Size: 87 patients.
- Data Provenance: Not explicitly stated, but implies clinical samples used for comparison with a predicate device. Retrospective or prospective nature is not specified.
- Test Set 2 (Blind Study):
- Sample Size: 99 samples (59 normal, 40 heterozygous S).
- Data Provenance: Not explicitly stated, but implied to be clinical samples previously tested by hemoglobin electrophoresis. Retrospective or prospective nature is not specified.
- Test Set 3 (Detection Limit Study):
- Sample Size: 10 heterozygous S samples.
- Data Provenance: Not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly mention the number or qualifications of experts used to establish the ground truth for the test sets.
- For Test Set 1 (Comparison Study), the ground truth was implicitly established by the results of the predicate device, Sicklequik, and blood typing for Hemoglobin S (66 contained no Hb S, 15 AS, 6 SS).
- For Test Set 2 (Blind Study), the ground truth for the 99 samples was established by "hemoglobin electrophoresis," which is a standard laboratory method, rather than expert consensus on device results. This implies a gold standard laboratory method was the ground truth.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by laboratory methods (predicate device results, hemoglobin electrophoresis) rather than subjective expert interpretation requiring 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. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool that involves human readers interpreting images or data with and without AI assistance to improve their performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance studies of the SICKLE-2000 device itself. The device is an in-vitro centrifugal solubility test, and its results are read directly, not requiring human interpretation in conjunction with an algorithm's output. The "blind study" specifically tests the device's ability to correctly identify samples without human bias.
7. The Type of Ground Truth Used
- For Test Set 1 (Comparison Study): The ground truth was primarily the results obtained from the predicate device, Sicklequik, and the classification of blood samples based on the presence/absence and type of Hemoglobin S (no Hb S, AS, SS). This can be considered a comparative ground truth against an established method.
- For Test Set 2 (Blind Study): The ground truth was established by hemoglobin electrophoresis, which is a definitive laboratory method for identifying hemoglobin types.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of device development or machine learning. The studies described are performance validation studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set (in the context of machine learning) is mentioned.
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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
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Product name: The trade name is SICKLE-2000. The common name is Sickle cell test or Sickle cell Hb solubility test.
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This is a class II device(21 CFR 864.7825, Sickle cell test).
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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.
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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.
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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.
- 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.
- The conclusion drawn from the above studies is that the device is safe, effective, and performs as well as the predicate device Sicklequik.
§ 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.