(91 days)
Not Found
No
The summary describes a mass spectrometry-based assay kit and associated software for measuring analyte concentrations. There is no mention of AI or ML in the device description, intended use, or performance studies. The analysis involves calculating percentiles and comparing concentrations to cut-offs, which is a standard statistical method, not AI/ML.
No
Explanation: The device is intended to aid in screening newborns for metabolic disorders by providing analyte concentration profiles, not to treat or cure these disorders. It is a diagnostic aid.
Yes
The product's intended use explicitly states that it "may aid in screening newborns for metabolic disorders," indicating its use in a diagnostic process.
No
The device is a kit containing reagents and consumables for laboratory testing, which are physical components, not software. While software is used with the kit and instruments, the kit itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "measurement and evaluation of amino acid, succinylacetone, free carnitine, acylcarnitine, nucleoside and lysophospholipid concentrations... from newborn heel prick blood specimens dried on filter paper." It also states that the results "may aid in screening newborns for metabolic disorders." This clearly indicates the device is used to examine specimens derived from the human body to provide information for diagnostic purposes (screening for metabolic disorders).
- Device Description: The device is a "kit" containing reagents and components specifically designed for performing these measurements on biological samples.
- Anatomical Site: The specimens are "newborn heel prick blood specimens dried on filter paper," which are human biological samples.
- Performance Studies: The document describes performance studies like precision, analytical sensitivity, linearity, interference, reproducibility, and screening performance, which are typical evaluations for IVD devices.
The definition of an In Vitro Diagnostic (IVD) device is a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
This device fits this definition.
N/A
Intended Use / Indications for Use
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.
Product codes
NOL
Device Description
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Newborn heel prick blood specimens
Indicated Patient Age Range
Newborns
Intended User / Care Setting
Routine screening laboratory in the United States
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Newborn population distributions were determined by measuring the analyte concentrations. Using data from routine newborn screening specimens, the cut-offs of the 3044-001U NeoBase 2 Non-derivatized MSMS kit analytes were determined by calculating analyte concentrations corresponding to the 1st, 10th, 99th and 99.5th percentiles. The percentiles and descriptive values calculated from results obtained from 2530 routine screening specimens are presented in the table on page 31.
The disorders and amount of confirmed positive specimens included in the study are listed in tables on page 32, 33, 34. In total, there were 19 specimens included in the group of amino acid disorders, 12 in the group of fatty acid oxidation disorders, 16 in the group of organic acid conditions and 5 in the group of other conditions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision: The precision was determined in accordance with CLSI document EP05-A3. The repeatability and within-laboratory variation for NeoBase 2 Non-derivatized MSMS kit is based on 80 determinations: 40 plates measured over 20 working days, each plate having 2 replicates per sample. One QSight was used. Between-lot variation is based on 75 determinations: 15 plates measured over five working days using three kit lots, each plate having 5 replicates per sample. One TQD was used. Between-instrument variation is based on altogether 50 determinations: 10 plates were measured with two QSights over 5 working days, each plate having 5 replicates per sample. The results are presented in tables from page 10 to 16.
Analytical Sensitivity: The analytical sensitivity (the lowest measurable analyte concentrations) has been demonstrated using two QSights. Results are summarized in the table on page 17.
Linearity: The linearity was determined in accordance with CLSI document EP06-A using one QSight. The assay is demonstrated to be linear as presented in the table on page 18-19.
Interference: The NeoBase 2 Non-derivatized MSMS kit was evaluated for interference in accordance with CLSI document EP07 using QSight. The substances potentially interfering with the assay and additional 9 substances that are abundant in the DBS sample matrix and have potential for unspecific effects on the test results were further tested. The substances potentially interfering with the assay were added into whole blood. The interference samples included NeoBase 2 Control analytes at two concentrations (below and above typical cut-off range). The NeoBase 2 surrogate analytes, which are not included in NeoBase 2 Controls, were studied at endogenous concentration level. The substances found not to interfere with the assay on QSight at the concentration indicated are listed in the table on page 19.
In the study, the following interferents were identified: Sarcosine, Creatine, L-Asparagine, L-Lysine, L-Glutamic acid, L-Methionine sulfone, Verapamil metabolite D617, L-Ornithine (Orn), Albumin, Intralipid (Triglycerides), Chlorhexidine digluconate, Hemoglobin, Benzocaine, C5 isomer pivalylcarnitine, C8 isomer valproylcarnitine, C3DC\C4OH, C4DC\C5OH and C5DC\C6OH, C16:1OHC17, C26:0-LPC, M+2 Isotopic Peaks, Plasticizers and contaminants from other consumables. Detailed descriptions of the interference and their impact are provided from page 19 to 24.
Reproducibility: Reproducibility of the NeoBase 2 Non-derivatized MSMS assay was determined on QSight across 2 external sites and one internal site. The reproducibility is based on 75 determinations: in each laboratory 5 plates measured over 5 working days using one kit lot and each plate having 5 replicates per sample. The results of reproducibility, between- and within-laboratory precisions are presented in the tables from page 25 to 31.
Screening Performance: The screening performance of the NeoBase 2 Non-derivatized MSMS kit on QSight and TQD platforms was compared in a clinical study at one routine screening laboratory in the United States. Newborn population distributions were determined by measuring the analyte concentrations. Using data from routine newborn screening specimens, the cut-offs of the 3044-001U NeoBase 2 Non-derivatized MSMS kit analytes were determined by calculating analyte concentrations corresponding to the 1st, 10th, 99th and 99.5th percentiles. The percentiles and descriptive values calculated from results obtained from 2530 routine screening specimens are presented in the table on page 31. The results for the screening performance data including confirmed positive specimens tested with QSight and TQD are presented in tables from page 32 to 34.
Key Results: The NeoBase 2 Non-derivatized MSMS kit demonstrates analytical and screening performance that supports its substantial equivalency with the predicate device, NeoBase 2 Non-derivatized MSMS kit (K173568).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Precision metrics (SD, CV%) and analytical sensitivity limits are provided. Percentiles (mean, median, 1st, 10th, 99th, 99.5th) from screening performance data are also presented.
Predicate Device(s)
NeoBase 2 Non-derivatized MSMS kit (K173568)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 7, 2020
PerkinElmer Inc. Eva Nalian Sr. Manager Regulatory Affairs 940 Winter Street Waltham, MA 02451
Re: K193103
Trade/Device Name: NeoBase 2 Non-derivatized MSMS Kit Regulation Number: 21 CFR 862.1055 Regulation Name: Newborn Screening Test System for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry Regulatory Class: Class II Product Code: NOL Dated: November 7, 2019 Received: November 8, 2019
Dear Eva Nalian:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Kellie B. Kelm, Ph.D. Acting Director Division Director of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name NeoBase™ 2 Non-derivatized MSMS kit
Indications for Use (Describe)
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.
Table 1. Analytes measured by the NeoBase 2 Non-derivatized MSMS kit.
| ANALYTE NAME | ABBREVIATION |
|---|---|
| Amino acids | |
| Alanine | Ala |
| Arginine | Arg |
| Argininosuccinic acid | Asa |
| Citrulline | Cit |
| Glutamine\Lysine 1 | Gln\Lys |
| Glutamic acid | Glu |
| Glycine | Gly |
| Leucine\Isoleucine\Hydroxyproline 1 | Leu\lle\Pro-OH |
| Methionine | Met |
| Ornithine | Orn |
| Phenylalanine | Phe |
| Proline | Pro |
| Tyrosine | Tyr |
| Valine | Val |
| Carnitines | |
| Free carnitine | C0 |
| Acetylcarnitine | C2 |
| Propionylcarnitine | C3 |
| Malonylcarnitine\3-Hydroxy-butyrylcarnitine 1 | C3DC\C4OH |
| Butyrylcarnitine | C4 |
| Methylmalonyl\3-Hydroxy-isovalerylcarnitine 1 | C4DC\C5OH |
| Isovalerylcarnitine | C5 |
| Tiglylcarnitine | C5:1 |
| Glutarylcarnitine\3-Hydroxy-hexanoylcarnitine 1 | C5DC\C6OH |
| Hexanoylcarnitine | C6 |
| Adipylcarnitine | C6DC |
1 Analytes in these rows are either isomers or isobars and cannot be distinguished in the tandem mass spectrometry experiment.
3
Table 1 (continued): Analytes measured by the NeoBase 2 Non-derivatized MSMS kit.
| Octanoylcarnitine | C8 |
|---|---|
| Octenoylcarnitine | C8:1 |
| Decanoylcarnitine | C10 |
| Decenoylcarnitine | C10:1 |
| Decadienoylcarnitine | C10:2 |
| Dodecanoylcarnitine | C12 |
| Dodecenoylcarnitine | C12:1 |
| Tetradecanoylcarnitine (Myristoylcarnitine) | C14 |
| Tetradecenoylcarnitine | C14:1 |
| Tetradecadienoylcarnitine | C14:2 |
| 3-Hydroxy-tetradecanoylcarnitine | C14OH |
| Hexadecanoylcarnitine (Palmitoylcarnitine) | C16 |
| Hexadecenoylcarnitine | C16:1 |
| 3-Hydroxy-hexadecanoylcarnitine | C16OH |
| 3-Hydroxy-hexadecenoylcarnitine\ | |
| Heptadecanoylcarnitine 1 | C16:1OH\C17 |
| Octadecanoylcarnitine (Stearoylcarnitine) | C18 |
| Octadecenoylcarnitine (Oleylcarnitine) | C18:1 |
| Octadecadienoylcarnitine (Linoleylcarnitine) | C18:2 |
| 3-Hydroxy-octadecanoylcarnitine | C18OH |
| 3-Hydroxy-octadecenoylcarnitine | C18:1OH |
| 3-Hydroxy-octadecadienoylcarnitine | C18:2OH |
| Ketones | |
| Succinylacetone | SA |
| Nucleosides | |
| Adenosine | ADO |
| 2'-deoxyadenosine | D-ADO |
| Lysophospholipids | |
| C24:0 lysophosphatidylcholine | C24:0-LPC |
| C26:0 lysophosphatidylcholine | C26:0-LPC |
1 Analytes in these rows are either isomers or isobars and cannot be distinguished in the tandem mass spectrometry experiment.
4
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned number is _K193103
| Submitted by: | PerkinElmer, Inc.
940 Winter Street
Waltham MA 02451 |
|-------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Eva Nalian
Tel: 647-633-8435 |
| Trade Name: | NeoBase 2 Non-derivatized MSMS kit |
| Common Name: | Newborn screening test system for amino acids, free
carnitine, and acylcarnitines using tandem mass spectrometry |
| Regulation: | 21 CFR 862.1055 |
| Classification: | II |
| Panel: | 75 Chemistry |
| Product Code: | NQL |
| Predicate device: | NeoBase 2 Non-derivatized MSMS kit (K173568) |
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1. Device Description:
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 ●
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Image /page/7/Picture/1 description: The image shows the logo for PerkinElmer. The logo features a stylized blue "P" shape with a pointed end, positioned above the company name. The text "PerkinElmer" is written in a bold, sans-serif font, with the "E" in "Elmer" slightly larger and in a lighter shade of blue. Below the company name, the tagline "For the Better" is written in a smaller, italicized font, also in blue.
2. Intended Use:
The NeoBase 2 Non-derivatized MSMS kit is intended for the measurement and evaluation of amino acid, succinylacetone, free carnitine, nucleoside and lysophospholipid concentrations (Table 1) with a tandem mass spectrometer from newborn heel prick blood specimens dried on filter paper. Quantitative analysis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
Table 1. Analytes measured by the NeoBase 2 Non-derivatized MSMS kit.
| ANALYTE NAME | ABBREVIATION |
|---|---|
| Amino acids | |
| Alanine | Ala |
| Arginine | Arg |
| Argininosuccinic acid | Asa |
| Citrulline | Cit |
| Glutamine\Lysine 1 | Gln\Lys |
| Glutamic acid | Glu |
| Glycine | Gly |
| Leucine\Isoleucine\Hydroxyproline 1 | Leu\lle\Pro-OH |
| Methionine | Met |
| Ornithine | Orn |
| Phenylalanine | Phe |
| Proline | Pro |
| Tyrosine | Tyr |
| Valine | Val |
| Carnitines | |
| Free carnitine | C0 |
| Acetylcarnitine | C2 |
| Propionylcarnitine | C3 |
| Malonylcarnitine\3-Hydroxy-butyrylcarnitine 1 | C3DC\C4OH |
| Butyrylcarnitine | C4 |
| Methylmalonyl\3-Hydroxy-isovalerylcarnitine 1 | C4DC\C5OH |
| Isovalerylcarnitine | C5 |
| Tiglylcarnitine | C5:1 |
| Glutarylcarnitine\3-Hydroxy-hexanoylcarnitine 1 | C5DC\C6OH |
| Hexanoylcarnitine | C6 |
| Adipylcarnitine | C6DC |
1 Analytes in these rows are either isomers or isobars and cannot be distinguished in the tandem mass spectrometry experiment.
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Table 1 (continued): Analytes measured by the NeoBase 2 Non-derivatized MSMS kit.
| Octanoylcarnitine | C8 |
|---|---|
| Octenoylcarnitine | C8:1 |
| Decanoylcarnitine | C10 |
| Decenoylcarnitine | C10:1 |
| Decadienoylcarnitine | C10:2 |
| Dodecanoylcarnitine | C12 |
| Dodecenoylcarnitine | C12:1 |
| Tetradecanoylcarnitine (Myristoylcarnitine) | C14 |
| Tetradecenoylcarnitine | C14:1 |
| Tetradecadienoylcarnitine | C14:2 |
| 3-Hydroxy-tetradecanoylcarnitine | C14OH |
| Hexadecanoylcarnitine (Palmitoylcarnitine) | C16 |
| Hexadecenoylcarnitine | C16:1 |
| 3-Hydroxy-hexadecanoylcarnitine | C16OH |
| 3-Hydroxy-hexadecenoylcarnitine\ | C16:1OH\C17 |
| Heptadecanoylcarnitine 1 | C17 |
| Octadecanoylcarnitine (Stearoylcarnitine) | C18 |
| Octadecenoylcarnitine (Oleylcarnitine) | C18:1 |
| Octadecadienoylcarnitine (Linoleylcarnitine) | C18:2 |
| 3-Hydroxy-octadecanoylcarnitine | C18OH |
| 3-Hydroxy-octadecenoylcarnitine | C18:1OH |
| 3-Hydroxy-octadecadienoylcarnitine | C18:2OH |
| Ketones | |
| Succinylacetone | SA |
| Nucleosides | |
| Adenosine | ADO |
| 2'-deoxyadenosine | D-ADO |
| Lysophospholipids | |
| C24:0 lysophosphatidylcholine | C24:0-LPC |
| C26:0 lysophosphatidylcholine | C26:0-LPC |
1 Analytes in these rows are either isomers or isobars and cannot be distinguished in the tandem mass spectrometry experiment.
3. Substantial Equivalency:
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| Characteristics | Proposed Device | Predicate (K173568) |
|---|---|---|
| Intended Use/ | ||
| Indications for Use | 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 with a tandem mass spectrometer | ||
| from newborn heel prick blood specimens dried on | ||
| filter paper. Quantitative analysis of these analytes | ||
| and their relationship with each other is intended to | ||
| provide analyte concentration profiles that may aid | ||
| in screening newborns for metabolic disorders. | Same | |
| Test Principle | Analytes in sample are measured by tandem mass | |
| spectrometry through analyte-specific mass | ||
| transitions appropriate for each type of analyte. The | ||
| extracted analytes are measured for set time | ||
| periods and compared to the signal intensities | ||
| produced by the corresponding isotope- labeled | ||
| internal standards. The concentrations are | ||
| determined by comparing the signal intensities of | ||
| the known standards to the measured analytes. | Same | |
| Disorders Screened | Amino-, organic-, and fatty acid metabolic disorders | Same |
| Analytes Measured | Amino acids, free carnitine, acylcarnitines, | |
| succinylacetone, nucleosides, and lysophospholipids | Same | |
| Instrument / Software | ||
| Platform | PerkinElmer QSight 210MD Screening System: QSight® Waters TQD instrument with MassLynx v4.1 | |
| HC Autosampler MD,QSight® Binary Pump MD, | ||
| Simplicity™ 3Q MD Software, PerkinElmer MSMS | ||
| Workstation Software | firmware, with Waters 1525 sample pump, | |
| with Waters 2777c autosampler, with Waters | ||
| NeoLynx v4.1 software and with the | ||
| PerkinElmer MSMS Workstation Software | ||
| Sample Type | Punch from dried blood spot specimen | Same |
| Calibrators | Internal calibration using several isotopically labeled | |
| standards, included as dried material in vials. | ||
| Internal standards must be reconstituted with | ||
| extraction solution prior to their use. | Same | |
| Throughput | Ninety-six tests per microtiter | |
| plate. Multiple plates can be analyzed | Same |
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The proposed device and predicate device utilize similar design shown to produce equivalent screening performance in a clinical setting. Both devices are intended for the measurement and evaluation of multiple metabolite concentrations from newborn heel prick blood samples dried on filter paper. Quantitative analysis of these analytes and their relationship with each other is intended to provide analyte concentration profiles that may aid in screening newborns for metabolic disorders.
4. Summary of the Studies:
Precision:
The precision was determined in accordance with CLSI document EP05-A3. The repeatability and withinlaboratory variation for NeoBase 2 Non-derivatized MSMS kit is based on 80 determinations: 40 plates measured over 20 working days, each plate having 2 replicates per sample. One QSight was used. Betweenlot variation is based on 75 determinations: 15 plates measured over five working days using three kit lots, each plate having 5 replicates per sample. One TQD was used. Between-instrument variation is based on altogether 50 determinations: 10 plates were measured with two QSights over 5 working days, each plate having 5 replicates per sample. The results are presented in the table below.
Repeatability, within-laboratory, between-lot, between-instrument and total variation determined for the NeoBase 2 Non-derivatized MSMS kit using QSight:
| Sample | Total
mean
μmol/L | Repeatability | | Within-Lab | | Between-lot | | Between-
instrument | | Total
Variation | |
|--------|-------------------------|---------------|-----|------------|-----|-------------|-----|------------------------|------|--------------------|-----|
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 161 | 11 | 6.5 | 17 | 9.8 | 4.1 | 2.8 | 19 | 12 | 26 | 16 |
| 2 | 361 | 21 | 5.5 | 27 | 7.1 | 6.2 | 1.8 | 17 | 4.6 | 32 | 9.0 |
| 3 | 414 | 24 | 5.4 | 30 | 6.8 | 4.2 | 1.0 | 3.4 | 0.84 | 30 | 7.3 |
| 4 | 518 | 28 | 5.3 | 34 | 6.3 | 15 | 3.1 | 0.04 | 0.01 | 37 | 7.2 |
Ala
Arg
| Sample | Total
mean
μmol/L | | Repeatability | | Within-Lab | | Between-lot | | Between-
instrument | | Total
Variation | |
|--------|-------------------------|------|---------------|------|------------|------|-------------|-------|------------------------|------|--------------------|--|
| | | SD | CV% | SD | CV% | SD | CV% | SD | CV% | SD | CV% | |
| 1 | 7.5 | 0.45 | 6.0 | 0.62 | 8.3 | 0.47 | 6.8 |