(56 days)
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 AxSYM Estradiol Standard Calibrators and AxSYM Estradiol Master Calibrators are devices intended for use in the AxSYM 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 ARCHITECT FSH Calibrators are devices intended for use in the ARCHITECT FSH assay test system to establish points of reference that are used in the quantitative determination of follicle-stimulating hormone (FSH) in human specimens. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal discorders
ARCHITECT LH Calibrators are devices intended for use in the ARCHITECT LH assay test system to establish points of reference 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.
ARCHITECT Progesterone Calibrators are devices intended for use in the ARCHITECT Progesterone assay test system to establish points of reference 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.
ARCHITECT Prolactin Calibrators are devices intended for use in the ARCHITECT Prolactin assay test system to establish points of reference 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
AxSYM Total T3 Standard Calibrators and AxSYM Total T3 Master Calibrators are devices intended for use in the AxSYM Total T3 assay test system to establish points of reference that are used in the quantitative determination of total T3 in human specimens. Total T3 measurements are used in the diagnosis and treatment of thyroid disease.
Abbott Immunoassay/Clinical Chemistry 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.
The provided text is a 510(k) summary for Immunoassay/Clinical Chemistry Calibrators, which are in vitro diagnostic devices. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than proving performance against specific acceptance criteria through a clinical study for a standalone medical device.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size, standalone performance, ground truth for training set) are not applicable to this type of submission.
However, I can extract the relevant information regarding the device's characteristics and the basis for its acceptance by the FDA (i.e., substantial equivalence).
Here's a summary tailored to the provided document:
Acceptance Criteria and Study Information for Abbott Immunoassay/Clinical Chemistry Calibrators (K032458)
The acceptance criteria for these devices are based on demonstrating "substantial equivalence" to legally marketed predicate devices, as guided by the FDA Guidance for Industry "Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators" issued February 22, 1999. This means the new devices (calibrators) must be as safe and effective as existing legally marketed calibrators.
The "study" or justification proving the device meets these criteria is a comparison to predicate devices, detailing similarities and differences, and asserting that any differences do not raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
Note: For calibrators, "performance" is generally demonstrated by their intended function of establishing reference points for quantitative assays and their chemical composition, rather than clinical efficacy metrics typical of a therapeutic device. The "Acceptance Criteria" here are derived from the similarities and the claim of substantial equivalence to the predicate.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (Characteristics of Subject Device) |
|---|---|
| Intended Use: Establish points of reference for quantitative determination of substances in human specimens. | Each calibrator is designed "for use in [specific assay] test system to establish points of reference that are used in the quantitative determination of [analyte] in human specimens." |
| Analyte Detection: For use with quantitative immunoassays detecting specific analytes (e.g., Estradiol, FSH, LH, Progesterone, Prolactin, Total T3). | Each calibrator is specifically named for its analyte (e.g., "Abbott ARCHITECT® Estradiol Calibrators") and explicitly states its intended use for quantitative determination of that analyte. |
| Matrix/Composition: Similar buffer or serum bases. | ARCHITECT Estradiol: Tris Buffer based. |
| AxSYM Estradiol: Tris Buffer based. | |
| ARCHITECT FSH: Bovine serum based. | |
| ARCHITECT LH: Calf serum based. | |
| ARCHITECT Progesterone: Human serum based. | |
| ARCHITECT Prolactin: Tris buffer based. | |
| AxSYM Total T3: Bovine serum based. | |
| Standardization/Traceability: Referenced to internal standards and/or international reference preparations. | Estradiol Calibrators: Standardized to internal reference standards (purity no less than 97% by HPLC for ARCHITECT; correlated with GCMS for AxSYM). |
| FSH Calibrators: Referenced against WHO FSH 2nd IRP 78/549. | |
| LH Calibrators: Referenced to WHO Luteinizing Hormone (LH) Human, Pituitary 2nd IRP 80/552. | |
| Prolactin Calibrators: Referenced to WHO 3rd International Standard 84/500 for Prolactin. | |
| Total T3 Calibrators: Signal matched to Abbott internal reference standards, traceable to USP Reference Standard L-Triiodothyronine (free acid), concentration by HPLC. | |
| Number of Levels: May vary but must be appropriate for establishing reference points. | ARCHITECT Estradiol, FSH, LH, Progesterone, Prolactin: 2 levels. |
| AxSYM Estradiol Standard: 6 levels. | |
| AxSYM Estradiol Master: 2 levels. | |
| AxSYM Total T3 Standard: 6 levels. | |
| AxSYM Total T3 Master: 2 levels. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not applicable. This submission does not involve a clinical "test set" in the traditional sense of patient samples for diagnostic performance evaluation. The "test" environment is the internal laboratory validation of the calibrator's chemical and functional properties.
- Data Provenance: Not applicable for patient data. The "data" provided is comparison data between the new calibrators and existing predicate calibrators, focusing on their chemical formulation, standardization, and intended use. This is internal company data.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable. Ground truth for a calibrator usually refers to the accuracy of the concentration values assigned to the calibrator levels, which is established through rigorous chemical and analytical methods, often traceable to international standards. It's not typically determined by human expert consensus on clinical cases.
- Qualifications of Experts: The experts involved would be analytical chemists and metrologists within Abbott Laboratories responsible for manufacturing, quality control, and standardization, ensuring accuracy and traceability.
4. Adjudication Method
- Adjudication Method: Not applicable. There is no adjudication required for this type of submission as there are no independent expert readings of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This type of study is not relevant for an in vitro diagnostic calibrator.
6. Standalone Performance Study (Algorithm Only)
- Standalone Performance Study: Not applicable. These are physical calibrator products, not algorithms. Their performance is validated through their ability to correctly calibrate an assay system, rather than standalone diagnostic accuracy.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" for calibrators is the assigned concentration value for each calibrator level, established through:
- Traceability to International Reference Standards: E.g., WHO International Reference Preparations for hormones.
- Analytical Methods: E.g., HPLC (High-Performance Liquid Chromatography) and Gas Chromatography/Mass Spectrometry (GCMS) for purity and concentration determination.
- Gravimetric Preparation: Manufacturing calibrators by precisely weighing highly pure substances.
- Internal Reference Standards: Carefully characterized and stable internal standards used for signal matching and calibration.
8. Sample Size for the Training Set
- Sample Size: Not applicable. There is no "training set" in the context of an AI/ML algorithm for these calibrator products. The calibrators themselves are "trained" or standardized through a manufacturing and quality control process using the ground truth methods mentioned above.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: As explained in point 7, the "ground truth" (assigned values for calibrator levels) is established through:
- Referencing international standards (WHO, USP).
- Analytical techniques (HPLC, GCMS) to determine purity and concentration of raw materials.
- Gravimetric preparation.
- Standardization against well-characterized internal reference standards.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.