(265 days)
3029-0010, 3309-001U
No
The summary describes a quantitative biochemical assay and its performance characteristics, with no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for quantitative determination of total galactose and galactose-1-phosphate concentrations in blood for screening newborns for galactosemia, not for treating a condition.
Yes
The device aids in screening newborns for galactosemia by quantitatively determining total galactose and galactose-1-phosphate concentrations in blood specimens, which is a diagnostic purpose to identify a disease state.
No
The device description explicitly states it is a "kit" containing reagents and is used with a "GSP® instrument," indicating it is a hardware-based diagnostic test system, 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 "quantitative determination of total galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia". This involves testing a sample taken from the human body (blood) in vitro (outside the body) to provide information about a physiological state (galactosemia).
- Device Description: The description details a "test system" and "kit" containing reagents used to perform assays on blood specimens. This is characteristic of an IVD.
- Anatomical Site: The sample is taken from "blood specimens dried on filter paper," which is a human biological sample.
- Indicated Patient Age Range: It is intended for "newborns," indicating a specific patient population for diagnostic purposes.
- Intended User / Care Setting: It is used in a "newborn screening laboratory," a setting where diagnostic testing is performed.
All these elements align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
Product codes
JIA
Device Description
The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays.
The kit contains the following components:
Calibrators have been prepared from human red blood cells enriched with galactose, and with ProClin 300 as preservative. The hematocrit value is 50 - 55 % to correspond to a hematocrit of a newborn. The calibrators have been calibrated against primary calibrators gravimetrically prepared using a U.S. Pharmacopeia Reference Standard Preparation for galactose.
Controls have been prepared from human blood enriched with galactose and galactose-1phosphate, and with ProClin 300 as preservative. Prior to dispensing the blood onto the filter paper, the hematocrit value of blood used in the controls preparation is adjusted to 50 - 55 % to correspond to a hematocrit of a newborn. The low control is approximately 4.0 mg/dL and the high control approximately 12 mg/dL.
All human source materials used in the preparation of kit components were tested and found to be non-reactive for the presence of HBsAg, anti-HIV 1 and 2, and HCV by FDA approved methods.
Neonatal Total Galactose Assay Reagent 1 - 3 lyophilized vials
Neonatal Total Galactose Assay Reagent 2 - 3 lyophilized vials
Neonatal Total Galactose Assay Buffer - 3 bottles, 40 ml
Neonatal Total Galactose Assay Reconstitution Solution - 1 bottle. 20 ml
Neonatal Extraction Solution - 2 bottles, 60 ml
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Blood specimens dried on filter paper
Indicated Patient Age Range
newborns
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Type: Non-Clinical Studies
Sample Size: Not Specified.
Key Results:
- Repeatability (within-plate variation) and within-laboratory variation determined with 40 plates (2 sample replicates/plate) over 20 working days with a single GSP instrument (80 results/sample).
- Between-instrument variation determined with 15 plates (5 sample replicates/plate) over 5 working days with three GSP instruments (75 results/sample).
- Between-lot variation determined with 15 plates (5 sample replicates/plate) of three kit lots over 5 working days with a single GSP instrument (75 results/sample).
- Total variation ranged from 10.0 to 13.9 %CV.
- Limit of Blank (LoB) for total galactose is 0.3 mg/dL (17 umo//L) (95th percentile of 150 blank samples).
- Limit of Detection (LoD) is 0.7 mg/dL (39 umol/L) based on 60 determinations of 6 low level samples.
- Limit of Quantitation (LoQ) is 1.2 mg/dL (67 umol/L), defined as the lowest concentration with a total CV equal to or less than 20 %.
- The method demonstrated linearity from 1.2 mg/dL (67 umol/L) to 50 mg/dL (2775 umol/L).
- Recovery of galactose, galactose-1-phosphate, and both combined from three contrived dried blood spot samples averaged 98%, 115% and 102% respectively.
- Interference studies were conducted with acetaminophen, conjugated bilirubin, and Intralipid, as well as hemoglobin in combination with elevated bilirubin. A bias exceeding ±15% was considered significant interference.
- Acetaminophen showed significant interference at concentrations of 4.13 mg/dL and 5.5 mg/dL for 5 mg/dL total galactose; 2.75 mg/dL, 4.13 mg/dL, and 5.5 mg/dL for 10 mg/dL total galactose; and 2.75 mg/dL, 4.13 mg/dL, and 5.5 mg/dL for 15 mg/dL total galactose.
- Conjugated bilirubin showed significant interference at concentrations of 16.6 mg/dL, 24.9 mg/dL, and 33.2 mg/dL for 5 mg/dL total galactose; 24.9 mg/dL and 33.2 mg/dL for 10 mg/dL total galactose; and 24.9 mg/dL and 33.2 mg/dL for 15 mg/dL total galactose.
- Intralipid showed significant interference at concentrations of 250 mg/dL, 375 mg/dL, 500 mg/dL, 750 mg/dL, 1130 mg/dL, and 1500 mg/dL for 5 mg/dL total galactose; 500 mg/dL, 750 mg/dL, 1130 mg/dL, and 1500 mg/dL for 10 mg/dL total galactose; and 750 mg/dL, 1130 mg/dL, and 1500 mg/dL for 15 mg/dL total galactose.
- Hemoglobin at 237 g/L and above in combination with a bilirubin level of 15 mg/dL showed significant interference at 5 mg/dL and 10 mg/dL total galactose concentrations.
- Hematocrit levels from 35% to 65% (Hemoglobin levels 12-22 g/dL, i.e. 120-220 g/L) found not to interfere at total galactose concentrations of 5, 10, and 15 mg/dL.
- No hook effect found with total galactose concentrations up to 500 mg/dL (27750 umol/L).
Type: Method Comparison Study
Sample Size: 139 (for comparison with 3029-0010 Neonatal Total Galactose kit), 545 (for comparison with 3309-001U GSP Neonatal Total Galactose kit).
Key Results:
- Comparison with 3029-0010 Neonatal Total Galactose kit (x) using weighted Deming regression:
- mg/dL: y= 1.05x - 0.29; 95% CI: slope (0.97; 1.12), intercept (-0.48; -0.10) (n=139)
- umol/L: y= 1.05x - 16; 95% CI: slope (0.97; 1.12), intercept (-27; -6) (n=139)
- Comparison with 3309-001U GSP Neonatal Total Galactose kit (x) using Deming regression:
- mg/dL: y = 1.00x + 0.33; 95% CI: slope (0.96; 1.04), intercept (0.25; 0.42) (n=545)
- umol/L: y = 1.00x + 18.6; 95% CI: slope (0.96; 1.04), intercept (13.7; 23.4) (n=545)
Type: Screening performance study
Sample Size: 2161 samples (7 confirmed positive samples and 2154 routine samples).
Key Results:
- Screening performance (95th percentile, GSP Neonatal Total Galactose test system (3309-002U) vs. 3309-001U):
- Overall percent agreement = 98.7 % (95%CI 98.1 % - 99.1 %)
- Positive percent agreement = 87.7 % (95%CI 80.3 % - 93.1 %)
- Negative percent agreement = 99.3 % (95%CI 98.9 % - 99.6 %)
- Screening performance (99th percentile, GSP Neonatal Total Galactose test system (3309-002U) vs. 3309-001U):
- Overall percent agreement = 99.4 % (95%CI 98.9 % - 99.6 %)
- Positive percent agreement = 74.1 % (95%CI 53.7% - 88.9 %)
- Negative percent agreement = 99.7 % (95%CI 99.3 % - 99.9 %)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall percent agreement, Positive percent agreement, Negative percent agreement. Actual values provided in "Summary of Performance Studies".
Predicate Device(s)
GSP Neonatal Total Galactose kit [K133652]
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1310 Galactose test system.
(a)
Identification. A galactose test system is a device intended to measure galactose in blood and urine. Galactose measurements are used in the diagnosis and treatment of the hereditary disease galactosemia (a disorder of galactose metabolism) in infants.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 6, 2019
PerkinElmer Inc. Brian Ciccariello Head of Regulatory & Medical Affairs - Americas 940 Winter Street Waltham, MA 02451
Re: K190335
Trade/Device Name: GSP Neonatal Total Galactose kit Regulation Number: 21 CFR 862.1310 Regulation Name: Galactose test system Regulatory Class: Class I, Reserved Product Code: JIA Dated: September 27, 2019 Received: September 30, 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/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,
Marianela Perez-Torres, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K190335
Device Name GSP Neonatal Total Galactose kit
Indications for Use (Describe)
The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
GSP Neonatal Total Galactose Kit
Image /page/3/Picture/1 description: The image shows the logo for PerkinElmer. The logo features the company name in a bold, sans-serif font, with the words "PerkinElmer" in black. Above the name is a blue graphic element that resembles a stylized "P" with an arrow pointing to the right. Below the name is the tagline "For the Better" in a smaller, italicized font.
510(k) Summary
This 510(k) Summary information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is K190335.
Date: November 5, 2019
| Submitted by: | PerkinElmer Inc.
940 Winter Street
Waltham, MA 02451 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brian Ciccariello
Head of Regulatory & Medical Affairs - Americas
Email: brian.ciccariello@perkinelmer.com
Phone: 781-663-5651 |
| Trade Name: | GSP Neonatal Total Galactose kit |
| Common Name: | Galactose test System |
| Regulation: | 21 CFR 862.1310 |
| Classification Name: | Galactose test System |
| Classification: | I, Reserved |
| Panel: | 75 Clinical Chemistry |
| Product Code: | JIA |
| Predicate Device: | GSP Neonatal Total Galactose kit [K133652] |
Device Description:
The GSP Neonatal Total Galactose test system measures total galactose, i.e. both galactose and galactose-1-phosphate, using a fluorescent galactose oxidase method. The fluorescence is measured using an excitation wavelength of 505 nm and an emission wavelength of 580 nm. The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays.
4
Image /page/4/Picture/1 description: The image shows the PerkinElmer logo. The logo consists of a blue abstract shape resembling a stylized "P" and an arrow pointing to the right. Below the shape, the word "PerkinElmer" is written in a bold, sans-serif font, with "Elmer" in a lighter shade of gray. Underneath "PerkinElmer", the phrase "For the Better" is written in a smaller, italicized font.
The kit contains the following components:
Calibrators have been prepared from human red blood cells enriched with galactose, and with ProClin 300 as preservative. The hematocrit value is 50 - 55 % to correspond to a hematocrit of a newborn. The calibrators have been calibrated against primary calibrators gravimetrically prepared using a U.S. Pharmacopeia Reference Standard Preparation for galactose.
Controls have been prepared from human blood enriched with galactose and galactose-1phosphate, and with ProClin 300 as preservative. Prior to dispensing the blood onto the filter paper, the hematocrit value of blood used in the controls preparation is adjusted to 50 - 55 % to correspond to a hematocrit of a newborn. The low control is approximately 4.0 mg/dL and the high control approximately 12 mg/dL.
All human source materials used in the preparation of kit components were tested and found to be non-reactive for the presence of HBsAg, anti-HIV 1 and 2, and HCV by FDA approved methods.
Neonatal Total Galactose Assay Reagent 1 - 3 lyophilized vials Neonatal Total Galactose Assay Reagent 2 - 3 lyophilized vials Neonatal Total Galactose Assay Buffer - 3 bottles, 40 ml Neonatal Total Galactose Assay Reconstitution Solution - 1 bottle. 20 ml Neonatal Extraction Solution - 2 bottles, 60 ml
Intended Use:
The GSP Neonatal Total Galactose kit is intended for the quantitative determination of total galactose (galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia using the GSP® instrument.
Comparison Chart:
Comparison of the GSP Neonatal Total Galactose device with its predicate:
| GSP Neonatal Total Galactose kit | ||
|---|---|---|
| Characteristics | Proposed Device | Predicate Device (K133652) |
| Intended | ||
| Use/Indications for | ||
| Use | The GSP Neonatal Total | |
| Galactose kit is intended for the | ||
| quantitative determination of total | ||
| galactose (galactose and | ||
| galactose-1-phosphate) | ||
| concentrations in blood specimens | ||
| dried on filter paper as an aid in | ||
| screening newborns for | ||
| galactosemia using the GSP® | ||
| instrument. | Same |
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Image /page/5/Picture/1 description: The image shows the logo for PerkinElmer. The logo consists of a blue stylized "P" above the company name in black, sans-serif font. Below the company name is the tagline "For the Better" in a smaller, italicized, blue font.
| Test Methodology | Enzymatic assay | Same |
|---|---|---|
| Detection Method | Fluorescence – measured at 505 | |
| nm and 580 nm wavelengths | Same | |
| Instrument Platform | GSP instrument, automated | |
| (K090846) | Same | |
| Sample Type | Dried blood spot | Same |
| Reportable Range | 1.2 - 50 mg/dL | 1.15 - 50 mg/dL |
| Lower Limits of | ||
| Measure | LoB = 0.3 mg/dL | |
| LoD = 0.7 mg/dL | ||
| LoQ = 1.2 mg/dL | LoB = 0.34 mg/dL | |
| LoD = 0.97 mg/dL | ||
| LoQ = 1.15 mg/dL | ||
| Calibrators | A - 0.5 mg/dL | |
| B - 2.5 mg/dL | ||
| C - 5.0 mg/dL | ||
| D - 10 mg/dL | ||
| E - 20 mg/dL | ||
| F - 50 mg/dL | A - 0.5 mg/dL | |
| B - 2.5 mg/dL | ||
| C - 5.0 mg/dL | ||
| D - 10.0 mg/dL | ||
| E - 20 mg/dL | ||
| F - 50 mg/dL | ||
| Part Number | 3309-002U | 3309-001U |
Summary of Non-Clinical Studies:
The variation of the 3309-002U GSP Neonatal Total Galactose assay was determined in three different studies using dried blood spot samples. The repeatability (within-plate variation) and within-laboratory variation were determined with 40 plates (2 sample replicates/plate) of a single kit lot measured over 20 working days with a single GSP instrument (80 results/sample). The between-instrument variation was determined with 15 plates (5 sample replicates/plate) of a single kit lot measured over 5 working days with three GSP instruments (75 results/sample). The between-lot variation was determined with 15 plates (5 sample replicates/plate) of three kit lots measured over 5 working days with a single GSP instrument (75 results/sample). Total variation ranged from 10.0 to 13.9 %CV.
The Limit of Blank (LoB) for total galactose is 0.3 mg/dL (17 umo//L), defined as the 95th percentile of a distribution of blank samples (n = 150). The Limit of Detection (LoD) is 0.7 mg/dL (39 umol/L) based on 60 determinations of 6 low level samples. The Limit of Quantitation (LoQ) is 1.2 mg/dL (67 umol/L), defined as the lowest concentration with a total CV equal to or less than 20 %.
For total galactose, the method has been demonstrated to be linear throughout the measuring range (from 1.2 mg/dL (67 umol/L) to 50 mg/dL (2775 umol/L)).
The recovery of galactose, galactose-1-phosphate, and both combined was determined from three contrived dried blood spot samples with an average recovery of 98%, 115% and 102% respectively.
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Image /page/6/Picture/1 description: The image shows the logo for PerkinElmer. The logo consists of a blue stylized "P" with an arrow shape incorporated into it. Below the symbol is the name "PerkinElmer" in bold, with the tagline "For the Better" underneath in a smaller, italicized font.
The potentially interfering substances were added to whole blood with three total galactose concentrations (5, 10, and 15 mg/dL). The substances indicated in the table below were found not to interfere with the assay. A bias exceeding ±15% is considered a significant interference.
| Total Galactose
conc. (mg/dL) | Acetaminophen
concentration
tested mg/dL | Percent change in
measured galactose
(%) | Significant
change |
|----------------------------------|------------------------------------------------|------------------------------------------------|-----------------------|
| 5 | 1.38 | -6.7 | No |
| | 2.75 | -13.5 | No |
| | 4.13 | -23.7 | Yes |
| | 5.5 | -24.3 | Yes |
| 10 | 1.38 | -9.8 | No |
| | 2.75 | -16.3 | Yes |
| | 4.13 | -20.3 | Yes |
| | 5.5 | -22.0 | Yes |
| 15 | 1.38 | -10.3 | No |
| | 2.75 | -18.5 | Yes |
| | 4.13 | -25.9 | Yes |
| | 5.5 | -29.5 | Yes |
| Total Galactose
conc. (mg/dL) | Conjugated bilirubin
concentration
tested mg/dL | Percent change in
measured galactose
(%) | Significant
change |
|----------------------------------|-------------------------------------------------------|------------------------------------------------|-----------------------|
| 5 | 8.3 | -7.8 | No |
| | 16.6 | -44.8 | Yes |
| | 24.9 | -90.5 | Yes |
| | 33.2 | -93.7 | Yes |
| 10 | 8.3 | -5.0 | No |
| | 16.6 | -13.9 | No |
| | 24.9 | -38.2 | Yes |
| | 33.2 | -84.5 | Yes |
| 15 | 8.3 | -1.4 | No |
| | 16.6 | -8.0 | No |
| | 24.9 | -24.5 | Yes |
| | 33.2 | -75.4 | Yes |
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Image /page/7/Picture/1 description: The image shows the logo for PerkinElmer. The logo consists of a blue stylized "P" shape with a triangle pointing to the right, followed by the name "PerkinElmer" in bold black font. Below the name, there is a tagline that says "For the Better" in a smaller, blue font. The "Elmer" part of the name is in gray.
Intralipid was found not to interfere up to added concentrations of 125 mg/dL total galactose, up to 375 mg/dL at 10 mg/dL total galactose, and up to 500 mg/dL at 15 mg/dL total galactose. When present above these amounts Intralipid may cause a false positive screening result for a sample with measured total galactose concentration close to the cut-off value.
| Total Galactose
conc. (mg/dL) | Intralipid
concentration tested
mg/dL | Percent change in
measured galactose (%) | Significant
change |
|----------------------------------|---------------------------------------------|---------------------------------------------|-----------------------|
| 5 | 125 | 1.1 | No |
| | 250 | 21.1 | Yes |
| | 375 | 29.7 | Yes |
| | 500 | 40.8 | Yes |
| | 750 | 58.2 | Yes |
| | 1130 | 97.1 | Yes |
| | 1500 | 126.0 | Yes |
| 10 | 125 | 6.2 | No |
| | 250 | 9.4 | No |
| | 375 | 11.8 | No |
| | 500 | 22.0 | Yes |
| | 750 | 40.2 | Yes |
| | 1130 | 53.0 | Yes |
| | 1500 | 67.6 | Yes |
| 15 | 125 | -4.3 | No |
| | 250 | 0.7 | No |
| | 375 | 8.7 | No |
| | 500 | 8.2 | No |
| | 750 | 22.3 | Yes |
| | 1130 | 37.2 | Yes |
| | 1500 | 50.2 | Yes |
In addition, hemoglobin in combination with elevated bilirubin concentration of 15 mg/dL was found to interfere with the assay by increasing the measured total galactose concentration (see the table below). Therefore, hemoglobin level at 237 g/L and above in combination with elevated bilirubin level may cause a false positive screening result for a sample with measured total galactose concentration close to the cut-off value.
8
Image /page/8/Picture/1 description: The image shows the logo for PerkinElmer. The logo features a blue abstract shape resembling a stylized "P" or an arrow pointing to the right. Below the symbol is the company name "PerkinElmer" in a bold, sans-serif font, with a registered trademark symbol next to it. Underneath the company name is the tagline "For the Better" in a smaller, italicized font.
| Total Galactose conc.
(mg/dL) | Hemoglobin
concentration tested g/L
at bilirubin level
15 mg/dL | Percent change in
measured galactose (%) | Significant change |
|----------------------------------|--------------------------------------------------------------------------|---------------------------------------------|--------------------|
| 5 | 103 | -11.7 | No |
| | 204 | 10.3 | No |
| | 223 | 7.1 | No |
| | 237 | 17.6 | Yes |
| 10 | 103 | -5.9 | No |
| | 204 | 14.2 | No |
| | 223 | 12.1 | No |
| | 237 | 17.6 | Yes |
| 15 | 103 | -12.3 | No |
| | 204 | 6.9 | No |
| | 223 | 12.0 | No |
| | 237 | 13.2 | No |
Hematocrit levels from 35% to 65% (Hemoglobin levels 12-22 g/dL, i.e. 120-220 g/L) were found not to interfere at total galactose concentrations of 5, 10, and 15 mg/dL.
Hook Effect:
No hook effect has been found with total galactose concentrations up to 500 mg/dL (27750 umol/L)
Summary of Method Comparison:
The 3309-002U GSP Neonatal Total Galactose kit (y) was compared with the 3029-0010 Neonatal Total Galactose kit (x) using routine newborn screening dried blood spot samples and dried adult human whole blood samples spiked with galactose and galactose-1-phosphate in the range of 1.2-50 mg/dL (67-2775 umol/L) when determined with the 3309-002U GSP Neonatal Total Galactose kit. The correlation from weighted Deming regression was found to be:
mg/dL: y= 1.05x - 0.29; 95% CI: slope (0.97; 1.12), intercept (-0.48; -0.10) (n=139) umol/L: y= 1.05x - 16; 95% CI: slope (0.97; 1.12), intercept (-27; -6) (n=139)
The 3309-002U GSP Neonatal Total Galactose kit (y) was compared with the 3309-001U GSP Neonatal Total Galactose kit (x) using routine newborn screening dried blood spot samples in the range of 1.2-50 mg/dL (67-2775 µmol/L) when determined with the 3309-002U GSP Neonatal Total Galactose kit. The correlation from Deming regression was found to be:
mg/dL: y = 1.00x + 0.33; 95% CI: slope (0.96; 1.04), intercept (0.25; 0.42) (n=545) umol/L: y = 1.00x + 18.6; 95% CI: slope (0.96; 1.04), intercept (13.7; 23.4) (n=545)
9
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Summary of screening performance study:
In a study conducted at one newborn screening laboratory in the United States, the screening performance of the new and predicate device was evaluated with a total of 2161 samples (7 confirmed positive samples and 2154 routine samples). The screening performance is shown below based on 95th and 99th percentile values.
Screening performance of GSP Neonatal Total Galactose test system (95th percentile)
| 3309-001U | ||||
|---|---|---|---|---|
| Screening | ||||
| positive | ||||
| ≥ 3.9 mg/dL | Screening | |||
| negative |