ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
Device Facts
| Record ID | K153365 |
|---|---|
| Device Name | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator |
| Applicant | Siemens Healthcare Diagnostics, Inc. |
| Product Code | JIX · Clinical Chemistry |
| Decision Date | Dec 18, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
Indications for Use
ADVIA Chemistry Enzyme 1 Calibrator is intended for in vitro diagnostic use in the calibration of Gamma-Glutamyl Transferase (GGT), Lactate Dehydrogenase P-L (LDPL), Lactate Dehvdrogenase L-P (LDLP), Cholinesterase (CHE), and Lipase (LIP) assays on the ADVIA Chemistry systems. ADVIA® Chemistry Enzyme 2 Calibrator is intended for in vitro diagnostic use in the calibration of Alanine Aminotransferase (ALT); Alanine Aminotransferase, Concentrated Reagents (ALT c); Alanine Aminotransferase (P5P) (ALTP5P); Alanine Aminotransferase (P5P), Concentrated Reagents (ALTP c); Aspartate Aminotransferase (AST); Aspartate Aminotransferase, Concentrated Reagents (AST_c); Aspartate Aminotransferase (PSP)(ASTP5P); and Aspartate Aminotransferase (P5P), Concentrated Reagents (ASTP_c) assays on the ADVIA Chemistry systems.
Device Story
Liquid, multi-analyte, bovine serum albumin-based calibrators; used to calibrate enzyme assays on ADVIA Chemistry systems. Calibrators are ready-to-use; no preparation required. Value assignment involves gravimetric addition of analytes to base matrix; verification performed on ADVIA 1800 Chemistry systems using Master Lot Calibrators. Healthcare providers use these to ensure accuracy of clinical chemistry assays; results affect clinical decision-making by providing standardized reference points for patient sample testing. Benefits include reliable, traceable calibration for diagnostic enzyme measurements.
Clinical Evidence
No clinical data. Bench testing only. Stability studies (shelf-life and open-vial) conducted per CEN 13640. Value assignment verified against Master Lot Calibrators with n=20 replicates; acceptance criteria met (mean concentration within ±15% of target).
Technological Characteristics
Liquid, bovine serum albumin-based matrix. Multi-analyte. Enzyme 1: 2.5 mL/vial; Enzyme 2: 1.5 mL/vial. Storage 2-8°C. Traceability to IFCC reference materials (IFCC-452, 453, 454), molar extinction coefficients, or internal standards. No software or electronic components.
Indications for Use
Indicated for in vitro diagnostic calibration of specific enzyme assays (GGT, LDPL, LDLP, CHE, LIP, ALT, AST variants) on ADVIA Chemistry systems. No specific patient population or contraindications described.
Regulatory Classification
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.)
Special Controls
*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.
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