(84 days)
Not Found
No
The summary describes a mass spectrometry-based assay kit and associated instrumentation for quantitative enzyme activity measurement. There is no mention of AI or ML in the intended use, device description, performance studies, or key metrics. The data processing software mentioned is standard for mass spectrometry data analysis, not indicative of AI/ML.
No
Explanation: The device is intended for screening and diagnostic aid by measuring enzyme activity, not for treating or preventing disease.
Yes
The device is intended as an "aid in screening newborns for the following lysosomal storage disorders (LSD)," which directly falls under the definition of a diagnostic device as it helps identify a disease state.
No
The device description explicitly states that the system is comprised of a kit (including substrates, standards, solutions, and controls) and a mass spectrometer instrument with associated hardware components (autosampler, pump). While software is mentioned for instrument control and data processing, it is part of a larger hardware-based system for performing laboratory tests.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for the "quantitative measurement of the activity of the enzymes... in dried blood spots (DBS) from newborn babies." This is a measurement performed in vitro (outside the body) on a biological sample (dried blood spot).
- Purpose: The analysis is intended as an "aid in screening newborns for the following lysosomal storage disorders (LSD)..." This clearly indicates a diagnostic purpose, specifically for screening.
- Device Description: The device is a "test system" that uses mass spectrometry to measure enzyme activity from a dried blood spot sample. This is a typical setup for an in vitro diagnostic test.
- Sample Type: The device uses "dried blood spots (DBS) from newborn babies," which are biological specimens.
- Performance Studies: The document describes performance studies like Precision, Limit of Blank, Detection and Quantification, Linearity, and Screening Performance, which are standard evaluations for IVD devices.
- Key Metrics: The document lists metrics like Sensitivity, Specificity, PPV, NPV, etc., which are commonly used to evaluate the performance of diagnostic tests.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K173829) is a strong indicator that this device is being submitted for regulatory review as an IVD, likely through the 510(k) pathway.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NeoLSD™ MSMS kit is intended for the quantitative measurement of the activity of the enzymes acid-9glucocerebrosidase (ABG), acid-sphingomyelinase (GAA), 8 galactocerebrosidase (GALC), agalactosidase A (GLA) and a-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Krabbe Disease, Fabry Disease, and Mucopolyaccharidosis Type I (MPS I) Disease.
Product codes (comma separated list FDA assigned to the subject device)
PQW, PQT, PQU, PQV, QCL, QCM
Device Description
The NeoLSD MSMS test system uses mass spectrometry to quantitatively measure the activity of six lysosomal enzymes simultaneously from a dried blood spot sample. The NeoLSD MSMS test system is comprised of:
- NeoLSD MSMS kit, including substrates, internal standards, solutions and controls
The NeoLSD MSMS Kit will contain sufficient reagents and consumables to perform 960 assays (10 x 96-well plates) as listed in the following table.
Components:
- Kit insert: Instructions for use
- QC certificate: QC certificate showing the kit lot specific Kit Control results determined by the manufacturer, and the 1 SD limits.
- Internal Standards Substrate Mix: 1 vial or several vials of stable-isotope standards and designed substrates, the dried substrates and internal standards are a mixture of the 6 synthetic substrates, the corresponding 6 stable-isotope labeled internal standards, and sodium oleate
- DBS controls: C1, C2, C3 control levels on DBS cassettes, manufactured from human blood with a hematocrit value of 45-50%.
- Assay buffer: 1 bottle of 40 mL buffer, ready-for-use succinate buffered (pH 4.7) salt solution
- Extraction Solution: Ethyl acetate
- Flow Solvent reconstitution solvent: The ready-for-use Flow Solvent contains acetonitrile, water, and formic acid.
- Incubation/Sampling plate: 20 x 96-well microplate, U-bottomed
- Extraction plate: 10 x 96-deep well microplate
- Aluminum foil microplate covers: 20 adhesive aluminum foil microplate covers
- Microplate covers: 10 x adhesive microplate covers
- Plate barcode labels: 30 plate barcodes
- The QSight Instrument is comprised of:
- QSight® 210 MD Mass Spectrometer
- QSight HC Autosampler MD Instrument Software
- QSight Binary Pump MD
- Simplicity Instrument control software
- Simplicity Data Processing software (by sample)
- PerkinElmer MSMS Workstation Data Processing Software
The NeoLSD MSMS kit evaluates enzyme activities by measuring the product generated when an enzyme reacts with a synthesized substrate to create a specific end product. The activities of the six lysosomal enzymes present in a 3.2 mm punch from a dried blood spot (DBS) are simultaneously measured by the NeoLSD MSMS kit. The punches are incubated with the assay reagent mixture which contains;
- six substrates, one corresponding to each lysosomal enzyme
- six stable-isotope mass-labeled internal standards (IS) each designed to chemically resemble each product generated
- a buffer to maintain the reaction pH, and to carry inhibitors to limit activity from competing enzymes if present and additives to enhance the targeted enzyme reactions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Dried blood spots (DBS) from newborn babies.
Indicated Patient Age Range
Newborn babies
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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
The NeoLSD kit precision was determined based on the recommendations of the CLSI guideline EP5-A2. The variation of the NeoLSD MSMS kit is based on 108 determination: 54 plates measured over 22 working days, each plate having 2 replicates per sample. The samples were measured on 3 QSight systems using 3 kit lots.
The limits of blank and detection were determined according to the CLSI guideline EP17-A2. The limit of blank (LoB) for the NeoLSD MSMS kit is defined as the 95th percentile of a distribution of blank samples determinations. The limit of detection (LoD) of the kit is based on 75 determinations done with low level samples for the QSight 210 MD Screening System.
The Limit of Quantitation (LoQ) is defined as the lowest activity fulfilling the total CV% requirement of the assay. For ABG, GLA and IDUA the CV% requirement is
§ 862.1488 Lysosomal storage disorder newborn screening test system.
(a)
Identification. A lysosomal storage disorder newborn screening test system is intended to measure lysosomal enzyme levels obtained from dried blood spot specimens on filter paper from newborns as an aid in screening newborns for a lysosomal storage disorder.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include information that demonstrates the performance characteristics of the device, including:
(i) Study results that adequately demonstrate the clinical validity of the device, which must include information supporting the link between the analyte being measured and the condition being screened. The clinical validity of the device must be demonstrated in a clinical validation study using either well-characterized prospectively or retrospectively obtained clinical specimens from the intended use population. Testing in the clinical validation study must be performed by operators representative of the types of operators intended to use the test. The study design of the clinical validation study must assess the effects of sample collection and processing steps on test performance. Confirmed positive specimens must have a diagnosis based on confirmatory diagnostic methods or clinically meaningful information regarding the status of the subject must be obtained.
(ii) The reference interval in the normal newborn population for the analyte or analytes measured by the device.
(iii) Study results demonstrating the level of carryover or drift affecting the device performance.
(iv) Study results demonstrating the concentrations of the limit of blank, limit of detection, and limit of quantitation of the device. Sample concentrations below the limit of quantitation must not be reported by the device.
(v) Study results, which must be collected using sample panels from at least three reagent lots and at least three instruments over more than 20 testing days, demonstrating the imprecision of the device. The sample panels must consist of blood spot specimens with a range of analyte concentrations that span the reportable range of the device and must include samples with concentrations in the screen positive range, samples with concentrations at each cutoff, and samples with concentration in the normal range.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) A warning that indicates that the test is not intended to diagnose lysosomal storage disorders.
(ii) A warning that indicates that test results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, and clinical evaluation as appropriate.
(iii) Detailed information on device performance, including the false positive rate and the false negative rate observed in the clinical study.
(iv) Information on device performance in any relevant subgroup (
e.g., age of newborn at time of sample collection, birth weight, sex, gestational age, race, ethnicity) observed in the clinical study.
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May 3, 2019
PerkinElmer Inc. Brian Ciccariello Sr. Manager Regulatory Affairs 940 Winter Street Waltham, MA 02451
Re: K190266
Trade/Device Name: NeoLSD MSMS Kit Regulation Number: 21 CFR 862.1488 Regulation Name: Lysosomal storage disorder newborn screening test system Regulatory Class: Class II Product Code: PQW, PQT, PQU, PQV, QCL, QCM Dated: February 6, 2019 Received: February 8, 2019
Dear Brian Ciccariello:
We have reviewed your 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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190266
Device Name NeoLSD MSMS Kit
Indications for Use (Describe)
The NeoLSD™ MSMS kit is intended for the quantitative measurement of the activity of the enzymes acid-9glucocerebrosidase (ABG), acid-sphingomyelinase (GAA), 8 galactocerebrosidase (GALC), agalactosidase A (GLA) and a-L-iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Krabbe Disease, Fabry Disease, and Mucopolyaccharidosis Type I (MPS I) Disease.
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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Image /page/3/Picture/1 description: The image shows the PerkinElmer logo. The logo consists of a blue icon that looks like a stylized "I" with an arrow pointing to the right. Below the icon, the word "PerkinElmer" is written in a bold, sans-serif font, with "Perkin" in black and "Elmer" in gray. Underneath "PerkinElmer", the phrase "For the Better" is written in a smaller, italicized font.
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 K190266
Date: February 06, 2019
| Submitted by: | PerkinElmer Inc
940 Winter Street
Waltham MA 02451 |
|----------------------|----------------------------------------------------------|
| Contact Person: | Brian Ciccariello
Tel: 781-663-5651 |
| Trade Name: | NeoLSD MSMS Kit |
| Common Name: | NeoLSD MSMS Kit |
| Regulation: | 21 CFR 862.1488 |
| Classification Name: | Lysosomal storage disorder newborn screening test system |
| Classification: | 75 Chemistry |
| Product Code: | PQW, PQT, PQU, PQV, QCL, QCM |
| Predicate device: | NeoLSD MSMS Kit (K173829) |
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Intended Use:
The NeoLSD MSMS Kit is intended for the quantitative measurement of the activity of the enzymes acid-ß- glucocerebrosidase (ABG), acid-sphingomyelinase (ASM), acid-a-glucosidase (GAA), β-galactocerebrosidase (GALC), α- galactosidase A (GLA) and α-L- iduronidase (IDUA) in dried blood spots (DBS) from newborn babies. The analysis of the enzymatic activity is intended as an aid in screening newborns for the following lysosomal storage disorders (LSD) respectively; Gaucher Disease, Niemann-Pick A/B Disease, Pompe Disease, Krabbe Disease, and Mucopolysaccharidosis Type I (MPS I) Disease.
Device Description:
The NeoLSD MSMS test system uses mass spectrometry to quantitatively measure the activity of six lysosomal enzymes simultaneously from a dried blood spot sample. The NeoLSD MSMS test system is comprised of:
-
- NeoLSD MSMS kit, including substrates, internal standards, solutions and controls
The NeoLSD MSMS Kit will contain sufficient reagents and consumables to perform 960 assays (10 x 96-well plates) as listed in the following table.
- NeoLSD MSMS kit, including substrates, internal standards, solutions and controls
| Component | Description |
|---|---|
| Kit insert | Instructions for use |
| QC certificate | QC certificate showing the kit lot specific Kit Control results determined by |
| the manufacturer, and the 1 SD limits. | |
| Internal Standards Substrate Mix | 1 vial or several vials of stable-isotope standards and designed substrates, |
| the dried substrates and internal standards are a mixture of the 6 synthetic | |
| substrates, the corresponding 6 stable-isotope labeled internal standards, | |
| and sodium oleate | |
| DBS controls | C1, C2, C3 control levels on DBS cassettes, manufactured from human blood |
| with a hematocrit value of 45-50%. | |
| Assay buffer | 1 bottle of 40 mL buffer, ready-for-use succinate buffered (pH 4.7) salt |
| solution | |
| Extraction Solution | Ethyl acetate |
| Flow Solvent reconstitution solvent | The ready-for-use Flow Solvent contains acetonitrile, water, and formic |
| acid. | |
| Incubation/Sampling plate | 20 x 96-well microplate, U-bottomed |
| Extraction plate | 10 x 96-deep well microplate |
| Aluminum foil microplate covers | 20 adhesive aluminum foil microplate covers |
| Microplate covers | 10 x adhesive microplate covers |
| Plate barcode labels | 30 plate barcodes |
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Image /page/5/Picture/1 description: The image shows the PerkinElmer logo. The logo consists of a blue "P" shape with an arrow pointing to the right. The text "PerkinElmer" is written in black, with the words "For the Better" written in blue below it. The logo is simple and modern, and the colors are bright and eye-catching.
-
- The QSight Instrument is comprised of:
- QSight® 210 MD Mass Spectrometer O
- QSight HC Autosampler MD Instrument Software O
- QSight Binary Pump MD O
- Simplicity Instrument control software: O
- Simplicity Data Processing software (by sample): O
- O PerkinElmer MSMS Workstation Data Processing Software
The NeoLSD MSMS kit evaluates enzyme activities by measuring the product generated when an enzyme reacts with a synthesized substrate to create a specific end product. The activities of the six lysosomal enzymes present in a 3.2 mm punch from a dried blood spot (DBS) are simultaneously measured by the NeoLSD MSMS kit. The punches are incubated with the assay reagent mixture which contains;
- six substrates, one corresponding to each lysosomal enzyme
- six stable-isotope mass-labeled internal standards (IS) each designed to chemically resemble each product generated
- . a buffer to maintain the reaction pH, and to carry inhibitors to limit activity from competing enzymes if present and additives to enhance the targeted enzyme reactions.
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Image /page/6/Picture/1 description: The image shows the logo for PerkinElmer. The logo features a blue abstract shape resembling a stylized "P" and an arrow pointing to the right. The text "PerkinElmer" is written in a bold, sans-serif font, with "Perkin" in black and "Elmer" in gray. Below the name is the tagline "For the Better" in a smaller, blue font.
Comparison Chart:
Comparison of the NeoLSD MSMS Kit with the predicate.
| Characteristics | Proposed Device | Predicate (K173829) |
|---|---|---|
| Intended Use/ | ||
| Indications for | ||
| Use | The NeoLSD MSMS Kit is intended for the | |
| quantitative measurement of the activity of the | ||
| enzymes acid-β- glucocerebrosidase (ABG), | ||
| acid-sphingomyelinase (ASM), acid-α- | ||
| glucosidase (GAA), β-galactocerebrosidase | ||
| (GALC), α- galactosidase A (GLA) and α-L- | ||
| iduronidase (IDUA) in dried blood spots (DBS) | ||
| from newborn babies. The analysis of the | ||
| enzymatic activity is intended as an aid in | ||
| screening newborns for the following | ||
| lysosomal storage disorders (LSD) respectively; | ||
| Gaucher Disease, Niemann-Pick A/B Disease, | ||
| Pompe Disease, Krabbe Disease, Fabry Disease, | ||
| and Mucopolysaccharidosis Type I Disease. | Same | |
| Test | ||
| Methodology | Quantitative mass spectrometric enzymatic | |
| activity assay | Same | |
| Instrument / | ||
| Software | ||
| Platform | PerkinElmer QSight 210MD SMS | |
| Screening System: CTC PAL RSI Sample | ||
| Manager, Spark Holland SPH1240 | ||
| Binary Pump. Instrument Software: | ||
| Simplicity, Data Processing software | ||
| and with the PerkinElmer MSMS | ||
| Workstation Software | Waters Acquity TQD instrument with MassLynx | |
| v4.1 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 |
| Reportable Range | ||
| (μmol/L/h) | IDUA: 0.19 – 22.3 | |
| GAA: 0.31 – 25.3 | ||
| ABG: 0.79 – 20.0 | ||
| GLA: 0.80 – 20.4 | ||
| ASM: 0.16 – 13.8 | ||
| GALC: 0.20 – 7.75 | IDUA: 0.34 – 17.2 | |
| GAA: 0.44 – 24.2 | ||
| ABG: 0.69 – 20.1 | ||
| GLA: 0.97 – 20.9 | ||
| ASM: 0.90 – 20.5 | ||
| GALC: 0.63 – 6.3 | ||
| Lower Limits of | ||
| Measure | ||
| (μmol/L/h) | IDUA: LoB=0.044, LoD=0.13, LoQ=0.19 | |
| GAA: LoB=0.080, LoD=0.31, LoQ=0.31 | ||
| ABG: LoB=0.114, LoD=0.79, LoQ=0.79 | ||
| GLA: LoB=0.519, LoD=0.80, LoQ=0.80 | ||
| ASM: LoB=0.046, LoD=0.16, LoQ=0.16 | ||
| GALC: LoB=0.120, LoD=0.20, LoQ=0.20 | IDUA: LoB=0.059, LoD=0.24, LoQ=0.34 | |
| GAA: LoB=0.073, LoD=0.39, LoQ=0.44 | ||
| ABG: LoB=0.165, LoD=0.63, LoQ=0.69 | ||
| GLA: LoB=0.476, LoD=0.97, LoQ=0.97 | ||
| ASM: LoB=0.110, LoD=0.27, LoQ=0.90 | ||
| GALC: LoB=0.106, LoD=0.34, LoQ=0.63 |
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Image /page/7/Picture/1 description: The image shows the PerkinElmer logo. The logo consists of a blue stylized "P" with an arrow shape incorporated into it. Below the symbol, the name "PerkinElmer" is written in a bold, dark gray font. Underneath the company name, the phrase "For the Better" is written in a smaller, light blue font.
| Calibrators /
Standards | Molecular Weights & Concentrations of Internal
Standards:
IDUA: 430.26 / 15.0 μΜ
GAA: 502.32 / 24.0 μΜ
ABG: 390.38 / 20.0 μΜ
GLA: 488.31/ 24.0 μΜ
ASM: 404.40/ 15.0 μΜ
GALC: 416.40 / 10.0 μΜ | | | | | | Same |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|------|---------------------|-------------|------|-------|
| Controls | 3 levels of control material, human blood based | | | | | | Same |
| Expected Values
(µmol/L/h) | | N | 0.1% | 0.2% | 0.3% | 2.5% | 97.5% |
| | IDUA | 2488 | 1.36 | 1.51 | 1.86 | 3.31 | 12.55 |
| | GAA | 2488 | 2.32 | 2.54 | 2.79 | 4.23 | 19.55 |
| | ABG | 2488 | 1.40 | 1.78 | 1.96 | 3.66 | 18.95 |
| | GLA | 2488 | 3.83 | 4.74 | 5.44 | 7.59 | 41.99 |
| | ASM | 2488 | 1.32 | 1.43 | 1.57 | 2.32 | 8.01 |
| | GALC | 2488 | 0.80 | 1.01 | 1.07 | 1.62 | 14.90 |
| | IDUA | 5041 | 2.06 | 2.55 | 2.62 | 3.82 | 13.2 |
| | GAA | 5041 | 2.33 | 2.69 | 2.92 | 4.28 | 17.5 |
| | ABG | 5041 | 2.85 | 3.16 | 3.33 | 4.74 | 20.1 |
| | GLA | 5041 | 3.04 | 3.37 | 3.62 | 4.81 | 25.8 |
| | ASM | 5041 | 2.12 | 2.21 | 2.37 | 3.15 | 12.9 |
| | GALC | 5041 | 0.43 | 0.52 | 0.56 | 0.95 | 9.34 |
| Precision | Sample Activity
Range | | | Sample CV%
Range | | | |
| | IDUA | 0.76-16.4 | | | 8.9%-15.8% | | |
| | GAA | 0.95-24.7 | | | 7.3%-12.8% | | |
| | ABG | 1.05-14.7 | | | 13.9%-22.8% | | |
| | GLA | 1.03-17.6 | | | 7.3%-16.1% | | |
| | ASM | 0.56-12.2 | | | 8.1%-14.5% | | |
| | GALC | 0.27-7.75 | | | 6.4%-13.4% | | |
| | IDUA | 0.92-15.7 | | | 8.7%-18.7% | | |
| | GAA | 1.29 - 22.4 | | | 6.9%-16.7% | | |
| | ABG | 1.15-19.3 | | | 12.5%-23.2% | | |
| | GLA | 1.23-19.3 | | | 9.1%-16.1% | | |
| | ASM | 0.92-21.5 | | | 10.4%-16.7% | | |
| | GALC | 0.45-5.58 | | | 11.4%-22.7% | | |
Summary of Studies:
Precision:
The NeoLSD kit precision was determined based on the recommendations of the CLSI guideline EP5-A2 and presented in the tables below. The variation of the NeoLSD MSMS kit is based on 108 determinations: 54 plates measured over 22 working days, each plate having 2 replicates per sample. The samples were measured on 3 QSight systems using 3 kit lots.
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Image /page/8/Picture/1 description: The image shows the PerkinElmer logo. The logo consists of a blue stylized "I" shape with an arrow pointing to the right. The text "PerkinElmer" is written in a bold font, with the "Elmer" portion in a lighter shade of gray. Below the company name is the tagline "For the Better" in a smaller, lighter blue font.
| ABG | n | Mean
µmol/L/h | Repeatability
SD | Repeatability
CV% | Within-lab
SD | Within-lab
CV% | Between-lot
SD | Between-lot
CV% | Total variation
SD | Total variation
CV% |
|-----|-----|------------------|---------------------|----------------------|------------------|-------------------|-------------------|--------------------|-----------------------|------------------------|
| 1 | 108 | 1.05 | 0.11 | 10.7 | 0.24 | 22.7 | 0.02 | 2.4 | 0.24 | 22.8 |
| 2 | 108 | 2.33 | 0.30 | 13.0 | 0.38 | 16.5 | 0.11 | 4.8 | 0.40 | 17.2 |
| 3 | 108 | 6.56 | 0.71 | 10.8 | 0.93 | 14.1 | 0.19 | 2.8 | 0.95 | 14.4 |
| 4 | 108 | 13.0 | 1.21 | 9.30 | 1.73 | 13.3 | 0.50 | 3.9 | 1.80 | 13.9 |
| 5 | 108 | 14.7 | 2.35 | 15.9 | 2.97 | 20.2 | 0.29 | 2.0 | 2.99 | 20.3 |
NeoLSD QSight 22-day precision results.
| GALC | n | Mean
µmol/L/h | Repeatability | | Within-lab | | Between-lot | | Total variation | |
|------|-----|------------------|---------------|------|------------|------|-------------|-----|-----------------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 108 | 0.27 | 0.03 | 10.1 | 0.04 | 13.2 | 0.01 | 2.1 | 0.04 | 13.4 |
| 2 | 108 | 0.56 | 0.05 | 8.3 | 0.07 | 12.6 | 0.02 | 3.6 | 0.07 | 13.1 |
| 3 | 108 | 2.58 | 0.18 | 7.1 | 0.19 | 7.3 | 0.02 | 0.8 | 0.19 | 7.4 |
| 4 | 108 | 4.74 | 0.24 | 5.1 | 0.30 | 6.4 | 0.03 | 0.6 | 0.30 | 6.4 |
| 5 | 108 | 7.75 | 0.78 | 10.0 | 0.82 | 10.5 | 0.34 | 4.4 | 0.89 | 11.4 |
| IDUA | n | Mean
µmol/L/h | Repeatability | | Within-lab | | Between-lot | | Total variation | |
|------|-----|------------------|---------------|------|------------|------|-------------|-----|-----------------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 108 | 0.76 | 0.11 | 15.1 | 0.12 | 15.6 | 0.02 | 2.3 | 0.12 | 15.8 |
| 2 | 108 | 1.33 | 0.12 | 9.1 | 0.18 | 13.5 | 0.03 | 2.4 | 0.18 | 13.7 |
| 3 | 108 | 2.71 | 0.20 | 7.2 | 0.25 | 9.2 | 0.09 | 3.3 | 0.26 | 9.7 |
| 4 | 108 | 7.75 | 0.55 | 7.0 | 0.69 | 8.9 | 0.04 | 0.5 | 0.69 | 8.9 |
| 5 | 108 | 16.4 | 1.78 | 10.8 | 2.01 | 12.2 | 0.34 | 2.1 | 2.04 | 12.4 |
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Image /page/9/Picture/0 description: The image shows the PerkinElmer logo. The logo consists of a blue stylized "P" and a blue triangle pointing to the right. To the right of the logo is the word "PerkinElmer" in black and gray. Below the word "PerkinElmer" is the phrase "For the Better" in blue.
| GLA | n | Mean
µmol/L/h | Repeatability | | Within-lab | | Between-lot | | Total variation | |
|-----|-----|------------------|---------------|------|------------|------|-------------|-----|-----------------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 108 | 1.03 | 0.11 | 10.7 | 0.16 | 15.9 | 0.03 | 2.6 | 0.17 | 16.1 |
| 2 | 108 | 2.46 | 0.19 | 7.5 | 0.26 | 10.4 | 0.04 | 1.7 | 0.26 | 10.5 |
| 3 | 108 | 6.44 | 0.49 | 7.6 | 0.64 | 9.9 | 0.01 | 0.2 | 0.64 | 9.9 |
| 4 | 108 | 12.2 | 0.58 | 4.8 | 0.95 | 7.8 | 0.20 | 1.6 | 0.97 | 7.9 |
| 5 | 108 | 17.6 | 1.15 | 6.5 | 1.27 | 7.2 | 0.15 | 0.8 | 1.28 | 7.3 |
| GAA | n | Mean
µmol/L/h | Repeatability | | Within-lab | | Between-lot | | Total variation | |
|-----|-----|------------------|---------------|------|------------|------|-------------|-----|-----------------|------|
| | | | SD | CV% | SD | CV% | SD | CV% | SD | CV% |
| 1 | 108 | 0.95 | 0.08 | 8.4 | 0.12 | 12.7 | 0.02 | 1.7 | 0.12 | 12.8 |
| 2 | 108 | 2.80 | 0.22 | 7.8 | 0.24 | 8.5 | 0.05 | 1.7 | 0.24 | 8.7 |
| 3 | 108 | 8.01 | 0.55 | 6.9 | 0.58 | 7.2 | 0.11 | 1.4 | 0.59 | 7.3 |
| 4 | 108 | 17.1 | 1.76 | 10.3 | 1.95 | 11.4 | 0.29 | 1.7 | 1.97 | 11.5 |
| 5 | 108 | 24.7 | 1.54 | 6.2 | 1.81 | 7.3 | 0.23 | 0.9 | 1.82 | 7.4 |
Limit of Blank, Detection and Quantification:
The limits of blank and detection were determined according to the CLSI guideline EP17-A2 and presented in the table below. The limit of blank (LoB) for the NeoLSD MSMS kit is defined as the 95th percentile of a distribution of blank samples determinations. The limit of detection (LoD) of the kit is based on 75 determinations done with low level samples for the QSight 210 MD Screening System.
| Enzyme | LoB | LoD |
|---|---|---|
| ABG | 0.114 | 0.79 |
| ASM | 0.046 | 0.16 |
| GALC | 0.120 | 0.20 |
| IDUA | 0.044 | 0.13 |
| GLA | 0.519 | 0.80 |
| GAA | 0.080 | 0.31 |
NeoLSD limit of blank (LoB) and limit of detection (LoD) with QSight.
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Image /page/10/Picture/1 description: The image shows the logo for PerkinElmer. The logo consists of a blue abstract shape resembling a stylized "P" and an arrow pointing to the right. To the right of the shape is the text "PerkinElmer" with "Perkin" in black and "Elmer" in gray. Below the company name is the text "For the Better" in blue.
The Limit of Quantitation (LoQ) is defined as the lowest activity fulfilling the total CV% requirement of the assay. For ABG, GLA and IDUA the CV% requirement is