Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a quantitative enzymatic assay and fluorescence measurement, with no mention of AI or ML terms or methodologies.

Therapeutic

No

The device is intended for the quantitative determination of GALT activity in blood specimens to aid in screening newborns for classical galactosemia, which is a diagnostic purpose, not a therapeutic one.

Diagnostic

Yes

This device is intended for the quantitative determination of GALT activity in blood specimens as an aid in screening newborns for classical galactosemia, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions a "GSP Instrument" which is a hardware component used to measure fluorescence. The assay itself is also described as an "adaptation of the quantitative enzymatic assay," indicating a chemical process, not purely software.

IVD (In Vitro Diagnostic)

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... GALT activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency". This involves testing a biological sample (blood) in vitro (outside the body) to provide information about a medical condition (galactosemia).
Device Description: It describes an "assay" and the measurement of "fluorescence" in blood specimens, which are typical characteristics of laboratory-based diagnostic tests performed on biological samples.
Patient Age Range: It specifies "newborns", indicating a medical application for a specific patient population.
Intended User / Care Setting: It mentions "adequately trained laboratory personnel performing newborn screening", further reinforcing its use in a clinical laboratory setting for diagnostic purposes.
Performance Studies: The inclusion of detailed performance studies (Precision, Linearity, Detection Limit, Analytical Specificity, Effect of hematocrit, Comparison Studies) and key metrics (Overall percent agreement, Positive percent agreement, Negative percent agreement) are standard requirements for demonstrating the analytical and clinical performance of an IVD.
Predicate Device: The mention of a "Predicate Device" with a K number (K950803) indicates that this device is being compared to a previously cleared medical device, a common process for IVDs seeking regulatory approval.

All these elements strongly indicate that the GSP Neonatal GALT kit is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This kit (GSPTM Neonatal GALT) is intended for the quantitative determination of galactose-1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSPTM instrument.

Product codes

KQP

Device Description

The GSPTM Neonatal GALT assay is an adaptation of the quantitative enzymatic assay of Beutler and Baluda. The fluorescence is measured with the GSP Instrument using an excitation wavelength of 355 nm and an emission wavelength of 460 nm. The GSP Neonatal GALT assay uses prompt fluorescence technology.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

newborns

Intended User / Care Setting

professional use only.

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)

Precision:
Study Type: Precision study in accordance with NCCLS (CLSI) document EP5-A2.
Sample Size: Samples S1-S8 with N ranging from 206 to 216. Each run consisted of 2 plates with 4 replicates per sample.
Key results:

Results using a full calibration curve on each plate:
- Sample S1 (2.5 U/dL): Within run SD 0.3, CV% 10.3; Within lot SD 0.4, CV% 14.3; Total SD 0.4, CV% 15.9.
- Sample S8 (22.5 U/dL): Within run SD 0.7, CV% 3.0; Within lot SD 1.1, CV% 4.9; Total SD 1.2, CV% 5.2.
Precision data using one calibration curve valid for 24 h:
- Sample S1 (2.4 U/dL): Within run SD 0.3, CV% 12.8; Within lot SD 0.3, CV% 14.3; Total SD 0.4, CV% 15.7.
- Sample S8 (22.4 U/dL): Within run SD 0.8, CV% 3.4; Within lot SD 1.2, CV% 5.3; Total SD 1.3, CV% 5.8.

Linearity:
Study Type: Linearity study in accordance with NCCLS document EP6-A.
Key results: The method has been demonstrated to be linear throughout the measuring range, from 2.5 U/dL to 25 U/dL.

Detection Limit:
Study Type: Detection limit determination in accordance with NCCL document EP17-A.
Sample Size: n=83 for LoB, 351 determinations for LoD, n=209 for LoQ.
Key results:

Limit of Blank (LoB): 1.6 U/dL (95th percentile of blank samples).
Limit of Detection (LoD): 2.5 U/dL.
Limit of Quantitation (LoQ): 2.5 U/dL (lowest activity with a total CV

Regulation Number and Section

§ 862.1315 Galactose-1-phosphate uridyl transferase test system.

(a)
Identification. A galactose-1-phosphate uridyl transferase test system is a device intended to measure the activity of the enzyme galactose-1-phosphate uridyl transferase in erythrocytes (red blood cells). Measurements of galactose-1-phosphate uridyl transferase are used in the diagnosis and treatment of the hereditary disease galactosemia (disorder of galactose metabolism) in infants.(b)
Classification. Class II.

Summary

0

510(k) Summary

This summary of 510(k) safety and effectiveness information is supplied in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510 (k) number is K100101

Date: June 10, 2010

| Submitted by: | Wallac Oy, Division of PerkinElmer Inc.
Mustionkatu 6
20750 Turku, Finland | | | | |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact Person: | | | | | |
| Primary: | Kay A. Taylor
Tele: 317 418-1735
Fax: 317 536-3064 | | | | |
| Secondary: | Kati Suonpaa
Tele: (011) +358 2 2678 402
Fax: (011) +358-2-2678357 | | | | |
| Trade Name: | GSP Neonatal GALT kit (3303-001U) | | | | |
| Common Name:
Regulation: | GSP Neonatal GALT kit (21 CFR 862.1315) | | | | |
| Classification Name:
Product Code: | Galactose-1-phosphate uridyl transferase test system
(KQP) | | | | |
| Predicate device: | Neonatal GALT (formerly Isolab Galactose-1-Phosphate
Uridyl Tranferase test) (K950803) | | | | |
| Device Description: | The GSPTM Neonatal GALT assay is an adaptation of the
quantitative enzymatic assay of Beutler and Baluda. The
fluorescence is measured with the GSP Instrument using
an excitation wavelength of 355 nm and an emission
wavelength of 460 nm. The GSP Neonatal GALT assay
uses prompt fluorescence technology. | | | | |
| Intended Use: | This kit (GSPTM Neonatal GALT) is intended for the
quantitative determination of galactose-1-phosphate uridyl
transferase (GALT) activity in blood specimens dried on
filter paper as an aid in screening newborns for classical
galactosemia caused by GALT deficiency using the GSPTM
instrument. | | | | |

1

Device Comparison:

GSP Neonatal GALT Test System
Characteristics	Proposed Device	Neonatal GALT (K950803)
Intended
Use/Indications for
Use	This kit (GSP Neonatal GALT) is
intended for the quantitative
determination of galactose-1-
phosphate uridyl transferase
(GALT) activity in blood
specimens dried on filter paper as
an aid in screening newborns for
classical galactosemia caused by
GALT deficiency.using the
GSPTM instrument.

Comparison of the GSP Neonatal GALT device with its predicate.

2

.

3

. Performance Characteristics

Precision:

Precision was determined in accordance with NCCLS (CLSI) document EP5-A2.

The variation of the GSP Neonatal GALT assay was determined using dried blood spot samples and controls, 3 kit lots, and 3 GSP instruments. The study was performed over 25 days in 27 runs each consisting of 2 plates with 4 replicates per sample. The analysis of variance approach was used to calculate the following:

RESULTS
Sample	n	Mean GALT activity (U/dL)	Within run variation		Within lot variation		Total variation
			SD	CV%	SD	CV%	SD	CV%
S1	209*	2.5	0.3	10.3	0.4	14.3	0.4	15.9
S2	216	3.1	0.3	8.6	0.4	12.6	0.4	13.1
S3	206*	3.9	0.2	6.1	0.3	8.3	0.3	8.6
S4	216	5.3	0.3	5.7	0.5	9.0	0.5	9.2
S5	216	7.1	0.3	3.8	0.5	7.4	0.5	7.6
S6	216	13.1	0.9	6.7	1.2	8.9	1.2	9.1
S7	216	18.3	0.6	3.1	0.9	5.1	1.0	5.4
S8	216	22.5	0.7	3.0	1.1	4.9	1.2	5.2

Precision data using a full calibration curve on each plate:

Some results have been excluded because of technical errors.

Precision data using one calibration curve valid for 24 h.

RESULTS
Sample	n	Mean
GALT
activity
(U/dL)	Within run
variation		Within lot
variation		Total variation
			SD	CV%	SD	CV%	SD	CV%
S1	209*	2.4	0.3	12.8	0.3	14.3	0.4	15.7
S2	216	3.0	0.4	12.2	0.4	13.3	0.4	13.6
S3	206*	3.9	0.3	7.6	0.3	8.8	0.3	9.0
S4	216	5.3	0.4	7.9	0.5	9.6	0.5	9.8
S5	216	7.0	0.4	5.7	0.6	7.9	0.6	8.3
S6	216	13.0	1.0	7.4	1.2	9.0	1.2	9.5
S7	216	18.2	0.7	3.8	1.0	5.5	1.1	6.0
S8	216	22.4	0.8	3.4	1.2	5.3	1.3	5.8

Some results have been excluded because of technical errors.

4

Linearity:

Linearity was determined in accordance with NCCLS document EP6-A.

For GALT activities over 4 U/dL, the maximum observed difference (%) between the linear and 3td order regression models is -2.6 %. For activities ≤ 4 U/dL, the maximum observed absolute difference between the models is 0.07 U/dL.

For GSP Neonatal GALT, the method has been demonstrated to be linear throughout the measuring range, from extends from 2.5 U/dL to 25 U/dL.

Detection Limit:

The limits of blank, detection and quantitation were determined in accordance with NCCL document EP17-A.

The Limit of Blank (LoB) for GSP Neonatal GALT kit is 1.6 U/dL, defined as the 95th percentile of a distribution of blank (GALT deficient) samples (n=83). The Limit of Detection (LoD) is 2.5 U/dL based on 351 determinations of five low level samples. The Limit of Quantitation (LoQ) is 2.5 U/dL, defined as the lowest activity with a total CV equal or less than 20% (n=209).

Analytical Specificity:

The GSP Neonatal GALT kit was evaluated for interference in accordance with CLSI document EP7-A2.

Whole blood with three different GALT activities (approximately 3, 6 and 12 U/dL) were enriched above the endogenous levels with possible interfering substances as presented below.

Icteric (unconjugated bilirubin (≤ 40 mg/dL blood), conjugated bilirubin (≤ 40 mg/dL blood)) and lipemic (Intralipid ≤ 1000 mg/dL blood) samples did not interfere with the assay. Ascorbic acid (≤ 3 mg/dL blood) and galactose (≤ 50 mg/dL blood) did not interfere with the assay at tested concentrations.

Glutathione did not interfere up to concentration of 18.8, 37.5 and 56.3 mg/dL blood at sample GALT activities of 3, 6 and 12 U/dL, respectively. Glutathione concentrations above these levels caused a decrease of up to 63% in GALT activity.

Galactose-1-phosphate (GAL-1-P) had no effect on the low GALT activity sample (3 U/dL), while a GAL-1-P concentration of 12.5 mg/dL blood interfered with the result of the samples with GALT activities 6 and 12 U/dL. The measured GALT result decreased up to 37%.

Total protein (HSA) had no effect on the high (12 U/dL) activity sample. HSA did not interfere up to added concentration of 3000 mg/dL blood, which is approximately two times higher than the normal endogenous concentration of normal neonates, at sample GALT activities 3 and 6 U/dL. Added HSA concentrations above this level caused an increase up to 30% in GALT activity.

5

The effect of hematocrit was tested by adjusting the amount of red blood cells with plasma on three whole blood samples with different GALT activities (approximately 25 U/dL"

6

Screening Performance

Cut-off values based on the 0.5th, 1.05, and 1.5th percentiles were used for both methods.

Samples that resulted in values below 2.5 U/dL were reported as"25 U/dL" and considered screen negative for classical galactosemia.

Please note that the cut-off values used in this section only apply to this study. If the measured median GALT activity of routine samples is lower than the values given in this section, a higher percentile should be used to determine the cut-off (see sections "SPECIMEN COLLECTION AND HANDLING" and "EXPECTED VALUES AND INTERPRETATION OF RESULTS").

| Neonatal

GALT kit	NG-1100/4100
GSP 3303-001U	Test Positive	Test Negative	Total
Test Positive	39*	5	44
Test Negative	3	2132	2135
Total	42	2137	2179

Screening performance using the 0.5th percentile

Includes all 33 retrospective low GALT activity screening specimens

Overall percent agreement = (39 + 2132) / (2179)* 100% = 99.6% (CI 99.3%-99.9%) Positive percent agreement = (39 / 42)* 100% = 92.9% (CI 83.9%-100%) Negative percent agreement = (2132 / 2137)*100% = 99.8% (CI 99.5%-100%)

Screening performance using the 1.0st percentile.

| Neonatal

GALT kit	NG-1100/4100
GSP 3303-001U	Test Positive	Test Negative	Total
Test Positive	45*	8	53
Test Negative	8	2118	2126
Total	53	2126	2179

Includes all 33 retrospective low GALT activity screening specimens

Overall percent agreement = (45 + 2118) / (2179)* 100% = 99.3% (CI 98.9%--99.7%) Positive percent agreement = (45 / 53)* 100% = 84. 9% (CI 74.3%-95.5%) Negative percent agreement = (2118 / 2126)*100% = 99.6% (CI 99.3%--99.9%)

7

Screening performance using the 1.5th percentile

| Neonatal

GALT kit	NG-1100/4100
GSP 3303-001U	Test Positive	Test Negative	Total
Test Positive	51*	14	65
Test Negative	10	2104	2114
Total	61	2118	2179

Includes all 33 retrospective low GALT activity screening specimens

Overall percent agreement = (51 + 2104) / (2179)* 100% = 98.9% (CI 98.4%-99.4%) Positive percent agreement = (51 / 61)* 100% = 83.6% (CI 73.5%-93.7%) Negative percent agreement = (2104 / 2118)*100% = 99.3% (CI 99.0%-99.7%)

8

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

PerkinElmer, Inc. c/o Ms. Kay A. Taylor Director, Regulatory and Clinical Affairs 8275 Carloway Road Indianapolis, IN 46236

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

JUN 1 1 2010

K100101 Trade/Device Name: GSP Neonatal GALT kit Regulation Number: 21 CFR § 862.1315 Regulation Name: Galactose-1-phosphate uridyl transferase test system Regulatory Class: Class II Product Code: KQP Dated: April 28, 2010 Received: April 30, 2010

Dear Ms. Taylor:

Re:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of medical devicerelated adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

9

Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80) , please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to (201) . For part 807.97). For questions regarding regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

10

Indications for Use Form

510(k) Number (if known): K100101

Device Name: GSP Neonatal GALT

Indications for Use:

The GSP Neonatal GALT kit is intended for the quantitative determination of r ne Sose - 1-phosphate uridyl transferase (GALT) activity in blood specimens dried on filter paper as an aid in screening newborns for classical galactosemia caused by GALT deficiency using the GSP™ instrument.

Prescription Use XXXX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K100101

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