(416 days)
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No
The device description and performance studies focus on a fluorescent enzymatic assay and statistical analysis of cut-off values, with no mention of AI or ML technologies.
No
The device is a diagnostic tool used for screening newborns for galactosemia, not for treating the condition.
Yes
The device is intended to aid in screening newborns for galactosemia by quantitatively determining total galactose concentrations in blood specimens. This function of identifying a medical condition makes it a diagnostic device.
No
The device description explicitly states it is a "kit" and uses a "fluorescent galactose oxidase method," indicating it includes physical reagents and likely hardware components for the assay, not just software.
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... in blood specimens dried on filter paper as an aid in screening newborns for galactosemia." This involves testing a biological sample (blood) in vitro (outside the body) to provide information about a medical condition (galactosemia).
- Device Description: The description details a "fluorescent galactose oxidase method" used to measure substances in the blood sample. This is a laboratory-based assay, characteristic of IVDs.
- Performance Studies: The document describes studies comparing the device to a predicate device using "routine newborn screening dried blood specimens." This type of testing and comparison is standard for evaluating the performance of IVD devices.
The definition of an IVD generally includes reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device fits that description by aiding in the screening for galactosemia in newborns.
N/A
Intended Use / Indications for Use
The 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.
Product codes (comma separated list FDA assigned to the subject device)
JIA
Device Description
The Neonatal Total Galactose kit makes use of a fluorescent galactose oxidase method. The assay measures total galactose, i.e. both galactose and galactose-1-phosphate. The following schematic summarizes the reactions that occur during the test procedure: GAL-1-P + H₂O -> AP -> GAL + P, GAL + O₂ -> GAO -> GHD + H₂O₂, HPPA + H₂O₂ -> POD -> HPPA dimer* + H₂O (GAL-1-P = Galactose-1-phosphate, AP = Alkaline phosphatase, GAL = Galactose, P = Phosphate, GAO = Galactose oxidase, GHD = D-galacto-hexadialdose, POD = Peroxidase, HPPA = 3-(p-hydroxyphenyl)propionic acid, * = Fluorescent) proportional to the concentration of galactose in the sample.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
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Indicated Patient Age Range
Newborns
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison: The PerkinElmer Neonatal Total Galactose kit (y) was compared with the BioRad QuantaseTM Neonatal Total Galactose Screening Assay (K990654). using routine newborn screening dried blood spot specimens in the range of 72 umol/L to 1970 umo//L (1.3-3.5 mg/dL) (determined with the PerkinElmer kit). The correlation was found to be: y = 0.6Sx + 1.73, r = 0.87 (n = 842).
Specificity/Recovery: Mean recovery of galactose in the presence of galactose, galactose-1-phosphate or galactose + galactose-1-phosphate was 79 - 81 %.
Interference: No interference with glucose, mannose, fructose, ascorbate, bilirubin, hemoglobin, protein BSA and acetaminophen. Glutathione (60 mg/dL) and lipemic samples (0.25 -1 g/dL) interfere with the assay.
Precision:
Intra-assay and total variation:
| Mean Galactose conc.(mg/dL) | Intra-assay (%CV) | Total variation (%CV) | n |
|---|---|---|---|
| 7.1 | 6.6 | 12.3 | 143 |
| 13.8 | 6.5 | 10.8 | 144 |
| 20.2 | 5.3 | 8.6 | 144 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
When the 95th percentile was used as a cut-off for both methods, the positive percent was 64% (73/114) and the overall percent agreement was 95.9% ((73+1956)/2116).
When the 99th percentile was used as a cut-off for both methods, the positive percent agreement was 72.4% (21/29) and the overall percent agreement was 99.2% ((21+2078)/2116).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
BioRad QuantaseTM Neonatal Total Galactose Screening Assay (K990654)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 for PerkinElmer. The logo consists of a stylized "P" symbol above the name "PerkinElmer". The "P" symbol is made up of a thick vertical line and a triangle shape. Below the name "PerkinElmer" is the word "precisely."
PerkinElme▶Life and Analytical Sciences Wallac Oy P.O. Box 10 FIN-20101 Turku, Finland Phone: +358 - (0)2 - 267 8111 Fax: +358 - (0)2 - 267 8357
510(k) Summary
AUG - 7 2008
This summary of 510(k) safety and effectiveness information is being submitted in Introduction accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510 (k) number is K071649 | ||
|---|---|---|
| Submitter | Name | |
| Address | Wallac Oy | |
| Mustionkatu 6 | ||
| 20750 Turku, Finland | ||
| Phone | ||
| Fax | +358-2-2678575 | |
| +358-2-2678357 | ||
| Contact Person | Helena Lundström | |
| Registration Manager | ||
| Date of Preparation | July 31, 2008 | |
| Device name | Trade Name | Neonatal Total Galactose Kit |
| Common Name | Enzymatic Methods, galactose | |
| Classification Name | Galactose Test System (21 CFR 862.1310) Class I | |
| Product Code | JIA | |
| Predicate device | BioRad QuantaseTM Neonatal Total Galactose Screening Assay (K990654) | |
| Description of | ||
| the device | The Neonatal Total Galactose kit makes use of a fluorescent galactose oxidase method. | |
| The assay measures total galactose, i.e. both galactose and galactose-1-phosphate. The | ||
| following schematic summarizes the reactions that occur during the test procedure: |
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Image /page/1/Picture/0 description: The image shows the PerkinElmer logo. The logo consists of a stylized "P" and a right-pointing triangle above the company name "PerkinElmer" in a sans-serif font. Below the company name is the word "precisely."
| GAL-1-P + H₂O | AP | GAL + P |
|---|---|---|
| GAL + O₂ | GAO | GHD + H₂O₂ |
| HPPA + H₂O₂ | POD | HPPA dimer* + H₂O |
| GAL-1-P | = | Galactose-1-phosphate |
| AP | = | Alkaline phosphatase |
| GAL | = | Galactose |
| P | = | Phosphate |
| GAO | = | Galactose oxidase |
| GHD | = | D-galacto-hexadialdose |
| POD | = | Peroxidase |
| HPPA | = | 3-( p -hydroxyphenyl)propionic acid |
| * | = | Fluorescent |
:
ﮨﮯ proportional to the concentration of galactose in the sample.
| Intended use | The 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. |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The Neonatal Total Galactose kit is substantially equivalent to the BioRad QuantaseTM |
| | Neonatal Total Galactose Screening Assay (K990654). |
:
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Image /page/2/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized "P" shape above the company name. Below the name is the word "precisely."
Device
Comparison The following table compares the Neonatal Total Galactose kit with the predicate device.
| Predicate Device | New Device | |
|---|---|---|
| Device characteristics | BioRad Quantase Total Galactose | |
| Screening Assay | Perkin Elmer Neonatal Total Galactose Kit | |
| Device Similarities | ||
| Intended use | The Quantase™ Neonatal Total | |
| Galactose Screening Assay is | ||
| intended for use as a screening | ||
| method for measuring the total | ||
| D(+)galactose concentrations in | ||
| newborn blood spot specimens. | The kit is intended for the quantitative | |
| determination of total galactose (galactose | ||
| and galacatose-1-phosphate) | ||
| concentrations in blood specimens dried | ||
| on filter paper as aid in screening | ||
| newborns for galactosemia. | ||
| Technology | Enzymatic assay | The same |
| Kit content | Calibrators/Standards, Controls and | |
| Enzymatic Reagents | The same, plus Assay Plates | |
| Specimen type | Newborn dried blood spot specimens | The same |
| Interpretation of | ||
| results | Standard curve | The same |
| Calibrator format | Dried blood spots | The same |
| Number of Controls | Two | The same |
| Control format | Dried blood spots | The same |
| Device Differences | ||
| Methodology | Colorimetric end point method | Prompt Fluorescence |
| Instrumentation | Plate reader | Victor2™ D Fluorometer or equivalent |
| Calibrators/standards: | ||
| Number of levels | Five | |
| (Four standard levels + Standard 0 | ||
| which is plain white paper) | Six | |
| (six calibrator levels) | ||
| Analytical sensitivity | 0.60 mg/dL | 1.3 mg/dL |
| Linearity | 0.6 to 55 mg/dL | 1.3 to 56 mg/dL |
| Measuring Range | 0.6 to 50 mg/mL | 1.3 to 40 mg/mL |
| Expected values | Mean total galactose concentration | |
| 1.05 mg/dL (n=462) measured with a | ||
| punch size of 3/16". | Median total galactose concentration, | |
| 1.7 mg/dL (n=2109) measured with a punch | ||
| size of 1/8". |
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Image /page/3/Picture/0 description: The image shows the PerkinElmer logo. The logo consists of a stylized "P" shape above the company name "PerkinElmer" in a bold, sans-serif font. Below the company name is the word "precisely."
:
| Specificity/Recovery | Mean recovery of D(+) galactose in
the presense of 100mg/dL of the
following sugars and D(+)galactose
metabolites was 95.07% (S:D:
7.49%).
D-(+)-Gucose
a-Lactose
D(-)Fructose
Sucrose
Maltose
D(+)Mannose
D-Mannitol
Galactitol
D-Galacturonic Acid
D-Glucuronic Acid
D(-)Ribose | | | Mean recovery of galactose in the presence of
galactose, galactose-1-phosphate or galactose
- galactose-1-phosphate was 79 - 81 %. | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|----|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-------------------------------------------|-----|
| Interference | No interference observed with
known antibiotics, non-antibiotics
and metabolites | | | No interference with glucose, mannose,
fructose, ascorbate, bilirubin, hemoglobin,
protein BSA and acetaminophen. Glutathione
(60 mg/dL) and lipemic samples (0.25 -1
g/dL) interfere with the assay. | | | |
| Precision | Intra-assay (1/8 punch size)
Mean D(+)
Galactose
conc.(mg/dL) | % CV | n | Intra-assay and total variation
Mean
Galactose
conc.(mg/dL) | Intra-
assay
(%CV) | Total
variation
(%CV) | n |
| | 1.06 | 13.99 | 20 | 7.1 | 6.6 | 12.3 | 143 |
| | 6.81 | 10.02 | 20 | 13.8 | 6.5 | 10.8 | 144 |
| | 14.23 | 6.67 | 20 | 20.2 | 5.3 | 8.6 | 144 |
| | 33.96 | 3.94 | 20 | | | | |
| | Total Assay ( 1/8 punch size)
Mean D(+)
Galactose
conc.(mg/dL) | % CV | n | Mean
Galactose
conc.(mg/dL) | Intra-
assay
(%CV) | Total
within lot
variation
(%CV) | n |
| | 1.43 | 17.42 | 39 | 3.5 | 7.8 | 12.7 | 80 |
| | 6.97 | 6.27 | 40 | 11 | 7.2 | 11.8 | 80 |
| | 14.53 | 7.43 | 40 | 23 | 6.0 | 8.4 | 80 |
| | 33.58 | 8.53 | 40 | 36 | 5.2 | 8.6 | 80 |
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Image /page/4/Picture/0 description: The image shows the logo for PerkinElmer. The logo consists of a stylized "P" symbol above the company name, with the word "precisely" written below. The "P" symbol is made up of a thick vertical line and an arrow pointing to the right. The word "PerkinElmer" is written in a bold, sans-serif font.
Method Comparison
The PerkinElmer Neonatal Total Galactose kit (y) was compared with the BioRad Quantase™ Neonatal Total Galactose Screening Assay (K990654). using routine newborn screening dried blood spot specimens in the range of 72 umol/L to 1970 umo//L (1.3-3.5 mg/dL) (determined with the PerkinElmer kit). The correlation was found to be:
$$\mathbf{y} = \mathbf{0.6Sx} + \mathbf{1.73}, \quad \mathbf{r} = \mathbf{0.87} \text{ (n = 842)}$$
The total galactose cut-off values by percentile for both the PerkinFilmer Neonatal Total Galactose kit and the predicate were determined by analyzing 2109 routine newborn screening dried blood specimens representing an US population. The results are shown in the table below:
| Total galactose cut-off values by percentile | ||||
|---|---|---|---|---|
| PerkinElmer kit | Predicate | |||
| µmol/L | mg/dL | µmol/L | mg/dL | |
| Median | 94 | 1.7 | 33 | 0.6 |
| 95th percentile | 283 | 5.1 | 233 | 4.2 |
| 97.5th percentile | 355 | 6.4 | 316 | 5.7 |
| 99th percentile | 461 | 8.3 | 521 | 9.4 |
| 99.5th percentile | 549 | 9.9 | 678 | 12.2 |
The screening summaries using the 95th and 99th percented in the tables below. The samples used in the study, representing an US population, included 2116 newborn dricd blood samples (2109 routine screening specimens and seven restrospective specimens of which three were diagnosed true positives for galactosemia).
In the tables below the screening positives (+) are samples ≥ cut-off and the screening negatives (-) arc samples