(91 days)
The NeoBase™ 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Each NeoBase 2 Non-derivatized MSMS kit contains reagents for 960 assays. The kit is designed to be used with NeoBase 2 Non-derivatized Assay Solutions consisting of Neo MSMS Flow Solvent and NeoBase 2 Extraction Solution and NeoBase 2 Succinylacetone Assay Solution.
- NeoBase 2 Internal Standards - 1 vial
- NeoBase 2 Controls Low, High - 3 filter paper cassettes (Whatman, no. 903) containing 3 spots of each level per cassette
- Microplate, U-bottomed - 20 plates
- Adhesive microplate covers - 20 sheets
- Barcode labels for the plates - 30 pcs (10 different barcodes, 3 pcs of each)
- Lot-specific quality control certificate
This kit contains components manufactured from human blood. The source materials have been tested by FDA-approved methods for hepatitis B surface antigen, anti-hepatitis C and anti-HIV 1 and 2 antibodies and found to be negative.
Instruments used: - . QSight® 210 MD Screening System is comprised of:
- QSight® 210 MD Mass Spectrometer
- QSight® HC Autosampler MD
- QSight® Binary Pump MD ●
- Simplicity™ 3Q MD Software
- PerkinElmer MSMS Workstation software ●
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Note: This document describes a medical device for newborn screening. Performance is demonstrated through analytical studies (precision, sensitivity, linearity, interference) and screening performance data comparing it to a predicate device, rather than human-in-the-loop studies common for AI/imaging devices. Thus, several sections typically relevant to AI-based devices (e.g., number of experts, adjudication methods, MRMC studies) are not applicable here.
Acceptance Criteria and Device Performance
The acceptance criteria for the NeoBase 2 Non-derivatized MSMS kit are implied by the comprehensive analytical and screening performance evaluation studies conducted. The goal is to demonstrate that the device performs equivalently to the legally marketed predicate device (NeoBase 2 Non-derivatized MSMS kit, K173568) and provides reliable results for newborn screening.
The reported device performance below highlights key analytical and screening metrics. Specific numerical acceptance criteria are not explicitly stated as hard thresholds (e.g., "CV must be
§ 862.1055 Newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry.
(a)
Identification. A newborn screening test system for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry is a device that consists of stable isotope internal standards, control materials, extraction solutions, flow solvents, instrumentation, software packages, and other reagents and materials. The device is intended for the measurement and evaluation of amino acids, free carnitine, and acylcarnitine concentrations from newborn whole blood filter paper samples. The quantitative analysis of amino acids, free carnitine, and acylcarnitines and their relationship with each other provides analyte concentration profiles that may aid in screening newborns for one or more inborn errors of amino acid, free carnitine, and acyl-carnitine metabolism.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry.” See § 862.1(d) for the availability of this guidance document.