(152 days)
No
The summary describes a biochemical assay kit and an instrument for measuring fluorescence. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
This device is for diagnosing galactosemia, not treating it.
Yes
The device is intended for the "quantitative determination of total galactose concentrations in blood specimens... as an aid in screening newborns for galactosemia," which directly indicates its use in identifying a disease state.
No
The device is a kit containing reagents and calibrators for a biochemical assay, which are physical components, not software. It is used with a separate instrument (GSP instrument) which is also hardware.
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 "kit" containing "reagents" used to perform "assays" on blood specimens. This is characteristic of an IVD.
- Performance Studies: The document includes performance studies evaluating the device's analytical and clinical performance (method comparison, screening performance), which are standard for IVD submissions.
- Predicate Device: A predicate device (K071649; Neonatal Total Galactose kit) is listed, which is another IVD.
- Reference Device: A reference device (K090846; GSP instrument, automated) is listed, which is the instrument used to run the IVD assay.
All these elements strongly indicate that the GSP Neonatal Total Galactose kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GSP Neonatal Total Galactose kit is intended for the quantitation 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.
Product codes (comma separated list FDA assigned to the subject device)
JIA
Device Description
The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. 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 kit contains the following components:
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 - 1 bottle, 60 ml
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.
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
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)
Summary of Non-Clinical Studies:
The variation of the GSP Neonatal Total Galactose assay was determined using dried blood spot samples, 3 kit lots, and 3 GSP instruments. The study was performed in 27 runs over 21 days, each run consisting of 2 plates with 4 replicates per sample. Total number of measurements was 216 per each of seven samples. Total variation ranged from 9.3 to 14.1 %CV.
The Limit of Blank (LoB) for total galactose is 0.34 mg/dL, defined as the 95th percentile of a distribution of blank samples (n = 150). The Limit of Detection (LoD) is 0.97 mg/dL based on 216 determinations of 4 low level samples. The Limit of Quantitation (LoQ) is 1.15 mg/dL, defined as the lowest concentration with a total CV equal to or less than 20%.
For the GSP Neonatal Total Galactose kit, the assay has been demonstrated to be linear throughout the measuring range (from 1.15 mg/dL to 50 mg/dL).
The recovery of galactose, galactose-1-phosphate, and both combined was determined from three contrived dried blood spot samples with an average recovery of 109%, 117% and 103%, respectively.
The potentially interfering substances were added to whole blood with three total galactose concentrations (5, 10, and 15 mg/dL). A bias exceeding ±15% is considered a significant interference. Acetaminophen and conjugated bilirubin were found to interfere with the assay by decreasing the measured total galactose concentration. Acetaminophen concentrations above 2.75 mg/dL and conjugated bilirubin concentrations above 16.6 mg/dL may cause a false negative screening result for a specimen with measured total galactose concentration close to the cut-off value.
Intralipid was found to not interfere up to added concentrations of 250 mg/dL at 5 and 10 mg/dL total galactose; and up to 375 mg/dl at 15 mg/dl total galactose. When present above these amounts Intralipid may cause a false positive screening result for a specimen with measured total galactose concentration close to the cut-off value.
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. Therefore, hemoglobin level at 198 g/L and above in combination with elevated bilirubin level may cause a false positive screening result for a specimen with measured total galactose concentration close to the cut-off value.
Hematocrit levels from 30% to 66% (Hemoglobin levels 102-230 g/L) were found not to interfere at total galactose concentrations of 5, 10 and 15 mg/dL.
The following substances were tested and found to not interfere with the measurement of total galactose for the concentration noted; Unconjugated bilirubin (20 mg/dL), ß-Nicotinamide adenine dinucleotide (100 umol/L), Glutathione (3 mmol/L), Human Serum Albumin (30 mg/mL), Ascorbate (6 mg/dL), D-glucose (1000 mg/dL), D-mannose (100 mg/dL), Dfructose (18 mg/dL), Ampicillin (152 umol/L), and Lithium heparin (0.375 mg/ml).
Summary of Internal Method Comparison and Screening Performance Studies:
The 3309-001U GSP Neonatal Total Galactose kit (y) was compared internally with the 3029-0010 Neonatal Total Galactose kit (x) using routine screening and spiked blood spot specimens, duplicate measurements, in the range of 1.3-40 mg/dL (72-2220 umol/L) in the 3029-0010 kit, the range in the 3309-001U kit being 1.15-50 mg/dL (64-2775 umol/L. The correlation from weighted Deming regression was found to be: mg/dL: y= 1.16x - 0.49; 95% CJ: slope (1.07; 1.26), intercept (-0.73; -0.25) (n=141).
The GSP Neonatal Total Galactose test system was designed with an adjusted calibration (shift of approximately 20%) to better align performance with CDC Newborn Screening Quality Assurance Program control material. Therefore current Neonatal Total Galactose users will observe an increased recovery with the GSP Neonatal Total Galactose when running the same samples on both test systems.
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 2320 samples (6 confirmed positive samples and 2314 routine samples). The screening performance is shown below based on 95.0 and 99.0 percentile values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Screening performance of GSP Neonatal Total Galactose test system (95.0 percentile):
Overall percent agreement = (82+ 2146) / 2320* 100% = 96.0 %
Positive percent agreement = (82/129) * 100% = 63.6 %
Negative percent agreement = (2146/ 2191) * 100% = 97.9%
Screening performance of GSP Neonatal Total Galactose test system (99.0 percentile):
Overall percent agreement = (16+ 2276) / 2320* 100% = 98.8%
Positive percent agreement = (16/30) * 100% = 53.3 %
Negative percent agreement = (2276/ 2290) * 100% = 99.4%
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.
Neonatal Total Galactose kit [K071649]
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.
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
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 K133652
Date: April 28, 2014
Submitted by:
Wallac Oy, a subsidiary of PerkinElmer Inc. 940 Winter Street Waltham, MA 02451
Wallac Oy Mustionkatu 6 Turku Finland 20750
Submission Contact Person: Primary: Jeanette Schier-Pugsley Director, Regulatory and Clinical Affairs 781-663-6025 Tel: Fax: 781-663-5969 Trade Name: GSP Neonatal Total Galactose kit (3309-001U) 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: Neonatal Total Galactose kit [K071649]; Wallac Ove
Device Description:
The GSP Neonatal Total Galactose kit contains sufficient reagents to perform 1152 assays. 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 kit contains the following components:
APR 2 8 2014
1
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 - 1 bottle, 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:
2
| GSP Neonatal Total Galactose kit | ||
|---|---|---|
| Characteristics | Proposed Device | Predicate (K071649) |
| 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. | This 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. | ||
| Test Methodology | Enzymatic assay | Same |
| Detection Method | Fluorescence - measured at 505 | |
| nm and 580 nm wavelengths | Fluorescence - measured at 340 nm | |
| and 405 nm wavelengths | ||
| Instrument | ||
| Platform | GSP instrument, automated | |
| (K090846) | Fluorometer, manual | |
| Sample Type | Dried blood spot | Same |
| Reportable Range | 1.15 - 50 mg/dL | 1.3 - 40 mg/dL |
| Lower Limits of | ||
| Measure | LoB = 0.34 mg/dL | |
| LoD = 0.97 mg/dL | ||
| LoQ = 1.15 mg/dL | LoB = 0.7 mg/dL | |
| LoD = 1.3 mg/dL | ||
| Calibrators | 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 | A - 0 mg/dL | |
| B - 1.5 mg/dL | ||
| C – 4.0 mg/dL | ||
| D - 9.0 mg/dL | ||
| E - 18 mg/dL | ||
| F -- 40 mg/dL |
Summary of Non-Clinical Studies:
The variation of the GSP Neonatal Total Galactose assay was determined using dried blood spot samples, 3 kit lots, and 3 GSP instruments. The study was performed in 27 runs over 21 days, each run consisting of 2 plates with 4 replicates per sample. Total number of measurements was 216 per each of seven samples. Total variation ranged from 9.3 to 14.1 %CV.
The Limit of Blank (LoB) for total galactose is 0.34 mg/dL, defined as the 95th percentile of a distribution of blank samples (n = 150). The Limit of Detection (LoD) is 0.97 mg/dL based on 216 determinations of 4 low level samples. The Limit of Quantitation (LoQ) is 1.15 mg/dL, defined as the lowest concentration with a total CV equal to or less than 20%.
For the GSP Neonatal Total Galactose kit, the assay has been demonstrated to be linear throughout the measuring range (from 1.15 mg/dL to 50 mg/dL).
3
The recovery of galactose, galactose-1-phosphate, and both combined was determined from three contrived dried blood spot samples with an average recovery of 109%. 117% and 103%. respectively.
The potentially interfering substances were added to whole blood with three total galactose concentrations (5, 10, and 15 mg/dL). A bias exceeding ±15% is considered a significant interference. Acetaminophen and conjugated bilirubin were found to interfere with the assay by decreasing the measured total galactose concentration (see the tables below). Acetaminophen concentrations above 2.75 mg/dL and conjugated bilirubin concentrations above 16.6 mg/dL may cause a false negative screening result for a specimen with measured total galactose concentration close to the cut-off value.
| Total Galactose
conc. (mg/dL) | Acetaminophen
Concentration tested
mg/dL | Percent change in
measured galactose
(%) | Significant
change |
|----------------------------------|------------------------------------------------|------------------------------------------------|-----------------------|
| 5 | 1.38 | -9.6 | No |
| | 2.75 | -9.3 | No |
| | 4.13 | -20.6 | Yes |
| | 5.5 | -22.4 | Yes |
| 10 | 1.38 | -7.1 | No |
| | 2.75 | -11.8 | No |
| | 4.13 | -20.4 | Yes |
| | 5.5 | -21.9 | Yes |
| 15 | 1.38 | -7.5 | No |
| | 2.75 | -11.6 | No |
| | 4.13 | -20.5 | Yes |
| | 5.5 | -21.8 | Yes |
| Total Galactose
conc. (mg/dL) | Conjugated bilirubin
Concentration tested
mg/dL | Percent change in
measured galactose
(%) | Significant
change |
|----------------------------------|-------------------------------------------------------|------------------------------------------------|-----------------------|
| 5 | 8.3 | -6.0 | No |
| | 16.6 | -10.3 | No |
| | 24.9 | -100 | Yes |
| | 33.2 | -100 | Yes |
| 10 | 8.3 | -1.6 | No |
| | 16.6 | -2.7 | No |
| | 24.9 | -16.3 | Yes |
| | 33.2 | -99.9 | Yes |
| 15 | 8.3 | 5.9 | No |
| | 16.6 | 9.3 | No |
| | 24.9 | 4.4 | No |
| | 33.2 | -25.6 | Yes |
4
Intralipid ' was found to not interfere up to added concentrations of 250 mg/dL at 5 and 10 mg/dL total galactose; and up to 375 mg/dl at 15 mg/dl total galactose. When present above these amounts Intralipid may cause a false positive screening result for a specimen 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 | 6 | No |
| | 250 | 10 | No |
| | 375 | 23 | Yes |
| | 500 | 33 | Yes |
| | 750 | 37 | Yes |
| | 1130 | 54 | Yes |
| | 1500 | 77 | Yes |
| 10 | 125 | 15 | No |
| | 250 | 13 | No |
| | 375 | 19 | Yes |
| | 500 | 19 | Yes |
| | 750 | 30 | Yes |
| | 1130 | 40 | Yes |
| | 1500 | 52 | Yes |
| 15 | 125 | 4 | No |
| | 250 | 13 | No |
| | 375 | 15 | No |
| | 500 | 24 | Yes |
| | 750 | 22 | Yes |
| | 1130 | 22 | Yes |
| | 1500 | 29 | 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 198 g/L and above in combination with elevated bilirubin level may cause a false positive screening result for a specimen with measured total galactose concentration close to the cut-off value .
| Total Galactose
conc. (mg/dL) | Hemoglobin
Concentration tested
g/L at Bilirubin level
15 mg/dL | Percent change in
measured galactose (%) | Significant
change |
|----------------------------------|--------------------------------------------------------------------------|---------------------------------------------|-----------------------|
| 5 | 102 | -0.8 | No |
| 5 | 198 | 26.3 | Yes |
| 5 | 217 | 5.1 | No |
Intralipid is a registered trademark of Fresenius Kabi AB.
5
| 10 | 230 | 4.0 | No |
|---|---|---|---|
| 102 | 2.2 | No | |
| 198 | 19.3 | Yes | |
| 217 | -11.0 | No | |
| 230 | 7.1 | No | |
| 15* | 102 | 3.5 | No |
| 198 | 5.8 | No | |
| 230 | 22.0 | Yes |
- Due to insufficient blood volume during sample preparation, a hemoglobin sample at 217 g/L could not be prepared at 15 mg/dL total galactose.
Hematocrit levels from 30% to 66% (Hemoglobin levels 102-230 g/L) were found not to interfere at total galactose concentrations of 5, 10 and 15 mg/dL.
The following substances were tested and found to not interfere with the measurement of total galactose for the concentration noted; Unconjugated bilirubin (20 mg/dL), ß-Nicotinamide adenine dinucleotide (100 umol/L), Glutathione (3 mmol/L), Human Serum Albumin (30 mg/mL), Ascorbate (6 mg/dL), D-glucose (1000 mg/dL), D-mannose (100 mg/dL), D-fructose (18 mg/dL), Ampicillin (152 umol/L), and Lithium heparin (0.375 mg/ml).
Summary of Internal Method Comparison and Screening Performance Studies:
The 3309-001U GSP Neonatal Total Galactose kit (y) was compared internally with the 3029-0010 Neonatal Total Galactose kit (x) using routine screening and spiked blood spot specimens. duplicate measurements, in the range of 1.3-40 mg/dL (72-2220 umol/L) in the 3029-0010 kit, the range in the 3309-001U kit being 1.15-50 mg/dL (64-2775 umol/L. The correlation from weighted Deming regression was found to be: mg/dL: y= 1.16x - 0.49; 95% CJ: slope (1.07; 1.26), intercept (-0.73; -0.25) (n=141).
The GSP Neonatal Total Galactose test system was designed with an adjusted calibration (shift of approximately 20%) to better align performance with CDC Newborn Screening Quality Assurance Program control material. Therefore current Neonatal Total Galactose users will observe an increased recovery with the GSP Neonatal Total Galactose when running the same samples on both test systems.
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 2320 samples (6 confirmed positive samples and 2314 routine samples). The screening performance is shown below based on 95.0 and 99.0 percentile values.
| GSP result | Manual
result | Total | Positive | Normal |
|------------|------------------|-------|----------|--------|
| + | + | 82 | 6 | 76 |
| + | - | 45 | 0 | 45 |
| - | + | 47 | 0 | 47 |
| - | - | 2146 | 0 | 2146 |
| Total | | 2320 | 6 | 2314 |
Screening performance of GSP Neonatal Total Galactose test system (95.0 percentile).
6
Overall percent agreement = (82+ 2146) / 2320* 100% = 96.0 % Positive percent agreement = (82/129) * 100% = 63.6 % Negative percent agreement = (2146/ 2191) * 100% = 97.9%
| Screening performance of GSP Neonatal Total Galactose test system (99.0 percentile). | ||||||||
|---|---|---|---|---|---|---|---|---|
| Manual | ||||||||
| I GSP result ! | Total | Dacitiva | Normsl |
| GSP result | result | Total | Positive | Normal |
|---|---|---|---|---|
| + | + | 16 | റ് | 10 |
| + | 14 | 0 | 14 | |
| + | 14 | C | 14 | |
| 2276 | 0 | 2276 | ||
| Total | 2320 | 6 | 2314 | |
| Overall percent agreement = (16+ 2276) / 2320* 100% = 98.8% | ||||
| Positive percent agreement = (16/30) * 100% = 53.3 % |
Negative percent agreement = (2276/ 2290) * 100% = 99.4%
Substantial Equivalency:
The proposed device and predicate device utilize similar enzymatic pathway and design shown to produce equivalent screening performance in a clinical setting. Both devices are intended for use in for the quantitative determination of total galactose and galactose and galactose-1-phosphate) concentrations in blood specimens dried on filter paper as an aid in screening newborns for galactosemia
Conclusion:
The GSP Neonatal Total Galactose test system demonstrates analytical and screening performance that supports its substantial equivalency with the predicate device, the Neonatal Total Galactose test system (K071649).
7
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G69 Silver Spring, MD 20993-0002
April 28, 2014
WALLAC OY. A SUBSIDIARY OF PERKIN ELMER. INC. C/O JEANETTE SCHIER-PUGSLEY DIRECTOR OF REGULATORY AFFAIRS 940 WINTER STREET WALTHAM MA 02451
Rc: K133652
Trade/Device Name: GSP Neonatal Total Galactose Kit Regulation Number: 21 CFR 862.1310 Regulation Name: Galactose test system Regulatory Class: 1. Reserved Product Code: JIA Dated: April 14, 2014 Received: April 15, 2014
Dear Ms. Jeanette Schier-Pugslev:
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 annroval 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. Iisting 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 cither 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 mav 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 vour 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 device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
8
Page 2-Ms. Schier-Pugsley
ff you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.htm. Also. please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/SafetyReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney H. Lias -S
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
9
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K133652
Device Name
GSP Neonatal Total Galactose kit
Indications for Use (Describe)
The GSP Neonatal Total Galactose kit is intended for the quantitation 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Yung W. Chan -S
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