(29 days)
Lyphochek Specialty Immunoassay Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.
Lyphochek Specialty Immunoassay Control is prepared from human serum with added chemicals, stabilizers, and preservatives. The control is provided in lyophilized form and contains the following analytes:
- Erythropoietin (EPO) .
- Procalcitonin .
- . Intact Parathyroid Hormone (Intact PTH)
- Sex Hormone Binding Globulin (SHBG) .
- Vitamin D .
Each human donor unit used to manufacture this control was tested by FDA accepted methods and found non-reactive for Hepatitis B Surface Antigen (HBsAg), antibody to Hepatitis C (HCV) and antibody to HIV-1/HIV-2.
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Device Acceptance Criteria and Study Details: Lyphochek Specialty Immunoassay Control
This 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study with pre-defined acceptance criteria for performance. The "acceptance criteria" here is implicitly demonstrated through the comparison of characteristics and the stability studies, showing the new device performs comparably and safely.
The Lyphochek Specialty Immunoassay Control is a quality control serum intended to monitor the precision of laboratory testing procedures for a list of analytes.
1. Table of Acceptance Criteria and Reported Device Performance
Since the submission is for substantial equivalence, the "acceptance criteria" are implied by demonstrating comparability to the predicate device and establishing appropriate stability profiles. The device performance is primarily described in terms of its stability characteristics.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device must perform its intended use (monitor precision of laboratory testing) comparably to the predicate device. | Demonstrated through "Value Assignment" process: Mean values and ±3SD ranges derived from replicate analyses, specific for each lot, using manufacturer-supported reagents and representative sampling. This implies the control will generate expected values. |
| Matrix Compatibility: Human serum matrix, similar to predicate. | Device matrix is Human Serum, identical to predicate. |
| Preservation & Stabilization: Contains preservatives and stabilizers, similar to predicate. | Device contains preservatives and stabilizers, identical to predicate. |
| Shelf Life Stability: Maintain integrity and expected values when unopened and stored under recommended conditions for a specified period. | Shelf Life Stability: 36 Months at 2 to 8°C (Established via Accelerated Stability Studies). |
| Reconstituted/Opened Vial Stability: Maintain integrity and expected values for a specified period after reconstitution/opening under recommended storage conditions. | Reconstituted Vial Stability: |
- Intact PTH: 12 days at 2°C to 8°C
- Procalcitonin: 3 days at 2°C to 8°C
- Erythropoietin (EPO), Sex Hormone Binding Globulin (SHBG), and Vitamin D: 30 days at 2 to 8°C (Established via Real-Time Stability Studies). |
| Frozen Aliquot Stability: Maintain integrity and expected values for a specified period when aliquoted and frozen under recommended storage conditions (new claim for candidate device). | Frozen Aliquot Stability: 30 days at -20°C to -70°C for all analytes (Established via Real-Time Stability Studies). |
| Safety: Manufacturing process for human-derived components ensures safety (e.g., non-reactive for major blood-borne pathogens). | Each human donor unit tested by FDA accepted methods and found non-reactive for HBsAg, anti-HCV, and anti-HIV-1/HIV-2. |
| Configuration: Appropriate packaging and fill volume for intended use (differences from predicate are noted but must be clinically acceptable). | Lyophilized form, 2 mL fill volume (MiniPak: Trilevel - 3 x 2 mL). These are noted differences from the predicate but are considered acceptable. |
| Analyte Content: Must contain the specified analytes and not contain analytes that would negatively impact its function as a control for its specified targets (differences from predicate are noted but must be clinically acceptable). Also, new analytes must have stability data.| Contains: EPO, Procalcitonin, Intact PTH, SHBG, Vitamin D.
Does not contain: Anti-Tg, Anti-TPO, C-Peptide, IGF-I, Osteocalcin. These are noted differences from the predicate but are considered acceptable, with stability data provided for the new analytes. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of a diagnostic accuracy study. The data provenance for the stability studies and value assignment involves "replicate analyses" and "representative sampling of the lot of product." The specific number of replicates or samples is not provided in this summary.
- Data Provenance: The studies were performed by the manufacturer and/or independent laboratories. No country of origin is explicitly stated, but the manufacturer is Bio-Rad Laboratories in Irvine, California, USA. The data would be prospective in nature, as it involves the testing of the manufactured control product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This device is a quality control (QC) material, not a diagnostic device that produces patient-specific results requiring expert interpretation or "ground truth" establishment in that sense.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a quality control product, not a diagnostic device where expert adjudication of results is necessary.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a quality control material and not an AI-assisted diagnostic tool. Therefore, an MRMC study and effect size of AI assistance are not relevant to this submission.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study: Not applicable. This is a physical quality control material and does not involve an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: For the "Value Assignment" of the control, the "ground truth" is established by generating mean values and corresponding ±3SD ranges through replicate analyses using manufacturer supported reagents and a representative sampling of the product lot. This is akin to a reference method or consensus measurement within the laboratory setting for defining the expected range of the control. For the primary purpose of this submission (substantial equivalence), the "ground truth" is the performance of the legally marketed predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a quality control material and does not employ a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an algorithm.
§ 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.