(57 days)
Abbott ARCHITECT® Estradiol Controls (LN 6C22) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Abbott ARCHITECT® Estradiol Controls (LN 2K25) are devices intended for use in the ARCHITECT® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Abbott AxSYM® Estradiol Controls are devices intended for use in the AxSYM® Estradiol assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Abbott FSH Controls are devices intended for use in the ARCHITECT, AxSYM, and IMx FSH assay test systems to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of folliclestimulating hormone (FSH) in human specimens. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders
Abbott ARCHITECT® LH Controls are devices intended for use in the ARCHITECT LH assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of luteinizing hormone (LH) in human specimens. LH measurements are used in the diagnosis and treatment of gonadal function.
Abbott ARCHITECT® Prolactin Controls are devices intended for use in the ARCHITECT Prolactin assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of prolactin in human specimens. Prolactin measurements are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.
Abbott ARCHITECT® Progesterone Controls are devices intended for use in the ARCHITECT® Progesterone assay test system to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of progesterone in human specimens. Progesterone measurements are used in the diagnosis and treatment of disorders of the ovaries or placenta.
Abbott ARCHITECT® Estradiol Calibrators are devices intended for use in the ARCHITECT® Estradiol assay test system to establish points of reference that are used in the quantitative determination of estradiol in human specimens. Estradiol measurements are used in the diagnosis and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Abbott Immunoassay/Clinical Chemistry Single Analyte Quality Control Materials (assayed) are devices intended for medical purposes for use in Abbott test systems to estimate test precision and to detect systematic analytical deviations that are used in the quantitative determination of values in the measurement of substances in human specimens.
Abbott ARCHITECT® Estradiol Calibrators are devices intended for medical purposes for use in Abbott assay test systems to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens.
This 510(k) summary (K041687) describes a submission for several quality control materials and calibrators for Abbott immunoassay/clinical chemistry systems. It is not a submission for an AI/ML medical device. Therefore, the information requested in the prompt, such as acceptance criteria, study details, sample sizes for test and training sets, expert involvement, and ground truth methodologies, is not applicable to this type of submission.
The document focuses on claiming substantial equivalence to legally marketed predicate devices and references FDA guidance documents for assays and calibrators. It does not contain data or studies related to AI/ML device performance.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.