(304 days)
The SPOTCHECK Neonatal GALT Microplate Reagent Kit is for the quantitative determination of galactose-1-phosphate uridyltransferase, EC 2.7.7.12 (GALT), activity in whole blood saturated filter paper disks, using a microplate absorbance reader. Measurements of GALT enzyme activity are used primarily in the diagnosis and treatment of the hereditary disease galactosemia. This method is intended for in vitro diagnostic use as an aid in neonatal screening for decreased levels of GALT enzyme activity, and not for monitoring purposes.
The SPOTCHECK Pro is used for automated sample processing in the application of in vitro diagnostic assays. Specimens containing patient bodily substances are introduced and analyzed in microtiter plates using qualitative/quantitative determination through absorbance measurements.
These devices are intended for use by trained, qualified laboratory personnel.
SPOTCHECK Neonatal GALT Microplate Reagent Kit - 60 Plate: Four enzyme mediated reactions are employed in the determination of GALT activity. GALT activity is determined by measuring the colored formazan produced by the addition of the color reagent to the incubated blood/substrate mixture. Patient samples of whole blood collected on standardized filter paper are placed into the wells of a standard 96 well microplate. A buffered enzyme mixture is added to each well and the plate is incubated at 37 °C for 120 minutes on a plate shaker/incubator. Following incubation, an aliquot of the mixture from each well is transferred to the corresponding wells on a clean 96 well microplate. Color reagent is added to each well, the color is developed over the course of 10 minutes, and the absorbance of each sample is determined on the plate reader. A blank absorbance reading is made prior to the addition of the color reagent to correct for endogenous sample color. The color developed is proportional (1:1) to the GALT activity in the sample. A standard curve prepared from a stock NADH solution is used to quantitate the results. Results are expressed as units of GALT enzyme activity per gram of hemoglobin or U/g Hb.
SPOTCHECK Pro: INSTRUMENT COMPONENTS: Tecan Freedom EVO and accessories necessary for assay.
This is a 510(k) premarket notification for a medical device, not an AI/ML device, therefore, some of the requested information (e.g., number of experts, adjudication method, MRMC study, sample size for training set) is not applicable or cannot be extracted from the provided text. The document describes the device's technical characteristics, performance studies performed to demonstrate substantial equivalence to a predicate device, and its intended use.
Here's an analysis of the provided information, tailored to what is available in the regulatory submission format:
1. Table of Acceptance Criteria (Performance Goals) and Reported Device Performance
The acceptance criteria are generally implied by the comparative studies to the predicate device and established CLSI guidelines for analytical performance. The studies aim to show the SPOTCHECK Kit performs comparably or better than the predicate device across various metrics.
| Performance Metric | Acceptance Criteria (Implied/Standard) | Reported Device Performance (SPOTCHECK Neonatal GALT Microplate Reagent Kit) |
|---|---|---|
| Linearity | Adherence to CLSI EP6-A; 2nd order regression from 0 to 15 U/g Hb. | Non-linear (2nd order regression) in the range of 0.25 to 15 U/g Hb. Confirmed by adherence to CLSI EP6-A. Calibration curve (NADH standards) conforms to a 2nd order regression from 0 to 15 U/g Hb. Results > 15 U/g Hb are reported as such. |
| Analytical Sensitivity (LoD) | Consistent with CLSI EP17-A; α |
§ 862.1315 Galactose-1-phosphate uridyl transferase test system.
(a)
Identification. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.(b)
Classification. Class II.