(262 days)
Not Found
No
The description focuses on automated bench chemistry and standard analytical techniques, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for in vitro diagnostic newborn screening and is not used for treatment or therapy.
Yes
This device is specifically described as an "in vitro diagnostic (IVD) instrument system" intended for "newborn screening" to identify "inborn errors in metabolism." The stated purpose is to screen for conditions like Galactosemia, Phenylketonuria, G6PD deficiency, and Tyrosinemia, which aligns directly with the function of a diagnostic device.
No
The device description explicitly states that the system consists of various devices that interact together, including an autosampler, pump, chemistry module, detector, and interface unit, in addition to the software. This indicates the presence of significant hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The SPOTCHECK Flow system is used for in vitro diagnostic newborn screening..." and "The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening...".
- Device Description: The "Device Description" section also states: "...to provide a complete in vitro diagnostic (IVD) instrument system for use with Astoria-Pacific's neonatal screening assays."
- Purpose: The device is intended to analyze biological samples (dried blood spots) in vitro (outside the body) to detect specific substances (enzymes and metabolites) that indicate the presence of certain inborn errors of metabolism. This is a core function of IVD devices.
- Intended Use: The intended use is for newborn screening, which is a diagnostic process.
- User: The intended users are "qualified clinical laboratory professionals," which is typical for IVD devices used in a clinical setting.
- Performance Studies: The document describes performance studies (Method Comparison, Sensitivity, Precision) conducted according to CLSI guidelines, which are standard for evaluating the performance of IVD devices.
All these points strongly indicate that the device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SPOTCHECK Flow system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:
- Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency . (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- . Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- Phenylalanine, elevated concentration (Phenylketonuria); . SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK . G6PD 50 Hour Reagent Kit
- Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK . Tyrosine 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:
- . Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour . Reagent Kit
- Galactose and galactose-1-phosphate, elevated total galactose . concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- Phenylalanine, elevated concentration (Phenvlketonuria); . SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK . G6PD 50 Hour Reagent Kit
- Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK . Tyrosine 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn error in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assay are:
- . Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:
- . Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- Galactose and galactose-1-phosphate, elevated total galactose . concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- . Phenylalanine, elevated concentration (Phenviketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- . Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit
- . Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
Product codes (comma separated list FDA assigned to the subject device)
KQP, JIA, JNB, JBL, CDR, NAK, JJC
Device Description
The SPOTCHECK continuous flow analyzer consists of various devices that interact together to provide a complete in vitro diagnostic (IVD) instrument system for use with Astoria-Pacific's neonatal screening assays. The technology can be considered automated bench chemistry in which continuously flowing reagents are mixed with the sample, ultimately producing a detectable product that correlates to analyte concentration. Proper conditions for reactions are controlled by using a variety of techniques such as specific timing for reagent inputs, incubation at specific temperatures, and/or dialysis. Depending upon the particular IVD assay, system components may differ slightly. In each case however, a system consists of an autosampler, a pump for reagents and sample streams, a module where assay chemistry occurs, a detector (including flowcell), and an interface unit that facilitates communication with the software.
The proposed modifications to the analyzer system components allow for 2 new unique system options; they are as follows:
-
- 350D Interface Unit: The predicate interface unit used for communications between detectors and software has been updated to accommodate the new software*.
OR
- 350D Interface Unit: The predicate interface unit used for communications between detectors and software has been updated to accommodate the new software*.
-
- 307 Digital Photometer/Fluorometer: A new detector has been developed as an alternative to using the interface unit and predicate fluorometric detector. It is intended to be used with the new software*.
AND
*NeoPac: A new software package has been developed to replace outdated software. The 2 options listed above both depend on this software to complete the system.
- 307 Digital Photometer/Fluorometer: A new detector has been developed as an alternative to using the interface unit and predicate fluorometric detector. It is intended to be used with the new software*.
NeoPac is a newly developed software package designed to replace Astoria-Pacific's predicate software package. It is intended for use with new components and Microsoft® operating systems currently on the market. The software facilitates similar instrument controls as the predicate package, while adding minor but important functionality.
The 350D facilitates electronic communication between NeoPac software and the detector(s), autosampler and pump. Each unit has 7 analog detector inputs on the front panel, a power cord connection, and cable connections for a PC, autosampler and pump. Its sole purpose is to provide a mechanism for commands and data to flow to and from the software and system components. The 350D is modified from the predicate device (350 Interface Unit) in order to communicate with new software.
The 307 detector is a newly developed detection platform intended to provide an alternative option to the interface unit and one or more detectors in the SPOTCHECK analyzer system. Aside from providing a state-of-the-art option for detection, its spatial requirements are significantly less than the predicate device. It can be manufactured with up to 4 unique photometric or fluorometric detection channels and an additional analog input (offering the ability to connect to a standalone detector). In conjunction with NeoPac software, it facilitates the communication of data and commands between a PC, autosampler and pump.
The 307 consists of a base module with up to 4 detection channels (not including a reference channel); each channel is either a fluorometer module or a photometric subassembly. The fluorometer module is a removable device that contains a flowcell, excitation LED, and emission bandpass filter. Each fluorometer module is manufactured according to the specifications of the assay it is intended to be used with. The photometric subassembly is not removable by the user.
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
neonatal
Intended User / Care Setting
qualified clinical laboratory professionals.
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
EP9-A2 Study:
Dried blood spots were obtained to represented both normal and deficient conditions for each of the 5 individual assays used on the SPOTCHECK system. Since patient samples with deficient and partially-deficient conditions are rare and especially difficult to obtain, in some cases dried blood spot controls provided by different manufacturers (including Astoria-Pacific and the Centers for Disease Control) were used to ensure adequate sample distribution across the assay range. Samples tested include responses around the medical decision levels for each individual assay. These levels were chosen using the cut-offs established in Astoria-Pacific's quality control laboratory.
Sample sizes: Total Galactose (69 samples), UT (GALT) (58 samples), Phenylalanine (70 samples), G6PD (60 samples), Tyrosine (71 samples). Replicates per Sample: 2 for all assays.
Additional Study of Newborn Specimens:
A second comparison study for each assay (Uridyltransferase (GALT), Total Galactose, Phenylalanine, and Tyrosine) was performed using a minimum of 88 newborn dried blood spots obtained from domestic newborn screening laboratories. The new G6PD study involved 50 newborn specimens, however the original study (described above) utilized a significant number of newborn specimens. The results of the G6PD study include 42 measurements from the previous study.
Sample sizes: Total Galactose (N=112, 96 newborns), Phenylalanine (N=112, 96 newborns), Tyrosine (N=101, 88 newborns), UT (GALT) (N=96, 94 newborns), G6PD (N=92, 92 newborns).
Sensitivity Study:
Evaluation of TGal, Phe, Tvr. and G6PD utilized 3 low-level samples analyzed over 3 days in batches of 20 low-level replicates and 20 blank replicates per run (for each method). Evaluation of GALT utilized 2 low-level samples analyzed over 3 days in batches of 20 low-level replicates and 20 blank replicates per run (1 low level sample was used in 2 of 3 runs, 40 replicates in total). The study was conducted according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline.
Precision Study:
Evaluation of precision for TGal, Phe, Tyr and GALT utilized 3 samples at different levels of activity or concentration (generally: low, medium, and high) for each method tested. Samples were analyzed over 5 days, 1 run per day, 8 replicates of each sample per run. Sample order was changed for each run. Evaluation of precision for G6PD also utilized 3 samples at low, medium and high activity, however, samples were analyzed over 4 days with 1 run per day for 3 days and 2 runs on one day. Eight replicates of each sample were analyzed per run in order to attain the degrees of freedom recommended in the protocol. Sample order was the same for each run. The study was conducted according to CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
EP9-A2 Study (Method Comparison and Bias Estimation):
Study type: Method Comparison and Bias Estimation.
Sample size: Total Galactose (69 samples), UT (GALT) (58 samples), Phenylalanine (70 samples), G6PD (60 samples), Tyrosine (71 samples). Replicates per Sample: 2.
Key results: The results of the EP9-A2 protocol demonstrate that there is no clinically-significant bias which would suggest a need for further analysis. The fluorometric assays performed nearly identical on both the 307 and predicate detector. Since the detection paradigms on the 307 are equivalent to the predicate device, the strong agreement was anticipated.
Additional Study of Newborn Specimens (Comparison Study):
Study type: Comparison Study.
Sample size: Total Galactose (N=112, 96 newborns), Phenylalanine (N=112, 96 newborns), Tyrosine (N=101, 88 newborns), UT (GALT) (N=96, 94 newborns), G6PD (N=92, 92 newborns).
Key results: The results from the second study closely match the original study and no clinically significant bias between detection paradigms was observed.
Sensitivity Study (Limit of Detection):
Study type: Sensitivity (Limit of Detection).
Sample size: TGal, Phe, Tyr, G6PD: 3 low-level samples, 20 low-level replicates and 20 blank replicates per run, analyzed over 3 days. GALT: 2 low-level samples, 20 low-level replicates and 20 blank replicates per run, analyzed over 3 days (one low level sample used in 2 of 3 runs).
Key results: The study results demonstrated equivalent or improved sensitivity performance when compared to the predicate system.
Precision Study:
Study type: Precision Performance.
Sample size: TGal, Phe, Tyr, GALT: 3 samples (low, medium, high), analyzed over 5 days, 1 run per day, 8 replicates per sample per run. G6PD: 3 samples (low, medium, high), analyzed over 4 days (1 run per day for 3 days, 2 runs on one day), 8 replicates per sample per run.
Key results: Each method's results demonstrated an improvement in precision over the predicate device at comparable levels of analyte/enzyme activity. The only exception is an observed increase in imprecision at very low levels of G6PD enzyme activity, however, said imprecision is acceptable and not clinically significant. Neither within-run nor total precision suggests that a neonate with deficient G6PD activity would be qualified as normal, especially considering the comparable precision around the clinical decision level.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
EP9-A2 Study:
- Total Galactose: Linear Regression slope (m)=1.02, intercept (b)=-0.58; Correlation Coefficient, R²=1.00; Bias at Xc (10 mg/dl)=-0.3.
- UT (GALT): Linear Regression slope (m)=0.96, intercept (b)=-1.49; Correlation Coefficient, R²=0.99; Bias at Xc (60 µM NADH)=-3.8.
- Phenylalanine: Linear Regression slope (m)=1.01, intercept (b)=-0.02; Correlation Coefficient, R²=1.00; Bias at Xc (4 mg/dl)=0.02.
- G6PD: Linear Regression slope (m)=1.00, intercept (b)=-1.24; Correlation Coefficient, R²=1.00; Bias at Xc (40 µM NADH)=-1.1.
- Tyrosine: Linear Regression slope (m)=1.01, intercept (b)=-0.05; Correlation Coefficient, R²=1.00; Bias at Xc (4 mg/dl)=0.01.
Additional Study of Newborn Specimens:
- Total Galactose: Slope=0.99 (95% Confidence: 0.98, 1.01); Intercept=-0.83 (95% Confidence: -0.73, -0.93); R²=0.99.
- Phenylalanine: Slope=0.99 (95% Confidence: 0.98, 0.99); Intercept=0.01 (95% Confidence: 0.0, 0.02); R²=1.00.
- Tyrosine: Slope=0.99 (95% Confidence: 0.98, 0.99); Intercept=0.01 (95% Confidence: 0.0, 0.02); R²=1.00.
- UT (GALT): Slope=1.03 (95% Confidence: 1.00, 1.07); Intercept=-7.6 (95% Confidence: -3.3, -12.0); R²=0.97.
- G6PD: Slope=0.97 (95% Confidence: 0.96, 0.98); Intercept=-0.56 (95% Confidence: -1.4, 0.28); R²=1.00.
Sensitivity (Limit of Detection - LoD):
- TGal: 307/NeoPac LoD=0.2 mg/dl; Predicate Device LoD=0.3 mg/dl.
- Phe: 307/NeoPac LoD=0.1 mg/dl; Predicate Device LoD=0.2 mg/dl.
- Tyr: 307/NeoPac LoD=0.2 mg/dl; Predicate Device LoD=0.2 mg/dl.
- GALT: 307/NeoPac LoD=3 µM NADPH; Predicate Device LoD=5 µM NADPH.
- G6PD: 307/NeoPac LoD=1 µM NADPH; Predicate Device LoD=2 µM NADPH.
Precision:
TGal - 307/NeoPac:
- Normal (Mean: 6.2 mg/dL): Sr=0.051, C.V.=0.82%, ST=0.214, %C.V.=3.4%.
- Near Cutoff (Mean: 11.3 mg/dL): Sr=0.118, C.V.=1.05%, ST=0.181, %C.V.=1.6%.
- Galactosemic (Mean: 31.4 mg/dL): Sr=0.168, C.V.=0.53%, ST=0.629, %C.V.=2.0%.
Phe - 307/NeoPac:
- Normal (Mean: 2.0 mg/dL): Sr=0.014, C.V.=0.70%, ST=0.065, %C.V.=3.3%.
- Near Cutoff (Mean: 4.5 mg/dL): Sr=0.028, C.V.=0.63%, ST=0.102, %C.V.=2.3%.
- Elevated (Mean: 15.3 mg/dL): Sr=0.065, C.V.=0.42%, ST=0.163, %C.V.=1.1%.
Tyr - 307/NeoPac:
- Normal (Mean: 1.8 mg/dL): Sr=0.036, C.V.=1.99%, ST=0.078, %C.V.=4.3%.
- Near Cutoff (Mean: 7.7 mg/dL): Sr=0.061, C.V.=0.79%, ST=0.187, %C.V.=2.4%.
- Tyrosinemic (Mean: 18.5 mg/dL): Sr=0.177, C.V.=0.96%, ST=0.780, %C.V.=4.2%.
GALT - 307/NeoPac:
- Galactosemic (Mean: 6.6 µM NADPH): ST=0.43, C.V.=5.18%, %C.V.=6.5%.
- Carrier (Mean: 62.5 µM NADPH): ST=2.86, C.V.=1.67%, %C.V.=4.6%.
- Normal (Mean: 122.0 µM NADPH): ST=4.51, C.V.=0.99%, %C.V.=3.7%.
G6PD - 307/NeoPac:
- Deficient (Mean: 3.4 µM NADPH): Sr=0.28, C.V.=8.15%, ST=0.30, %C.V.=8.7%.
- Near Cutoff (Mean: 39.7 µM NADPH): Sr=0.53, C.V.=1.33%, ST=2.04, %C.V.=5.1%.
- Normal (Mean: 83.1 µM NADPH): Sr=1.18, C.V.=1.42%, ST=5.40, %C.V.=6.5%.
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.
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.
Not Found
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
§ 862.1315 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.
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I N T E R N A T I O N A L
FEB - 4 2011
510(k) Summary - SPOTCHECK® Flow - K101392
1. Name, Address of Contact
Astoria-Pacific, Inc. FDA Establishment No. 3050015 15130 SE 82nd Drive Post Office Box 830 Clackamas, OR 97015-0830
Tel 1-503-657-3010 Fax 1-503-655-7367
Charles A. Peterson CEO
Jason Reynolds Official Correspondent
2. Name of the Device
Product Classification
| Regulation Number: | 21 CFR 862.2150 |
|---|---|
| Classification Panel: | Clinical Chemistry |
| Product Code: | JJC |
| Product Code Name: | Analyzer, Chemistry (Sequential Multiple, Continuous Flow) |
| Clinical Use | |
| Device Classification: | Class I |
Product Nomenclature
| Common Name: | Continuous Flow Analyzer |
|---|---|
| Proprietary Name: | SPOTCHECK® Flow |
| Model Number(s): | 350D Interface Unit; 307 Digital Photometer/Fluorometer; and |
| NeoPac™ Software |
3. Identification of the legally-marketed device for which substantial equivalence is claimed
The proposed devices are new components of Astoria-Pacific's FDA-cleared SPOTCHECK Analyzer system with associated 510(k) numbers K883020 and K851542.
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4. Description of the Device ·
- Astoria-Pacific SPOTCHECK Flow (system marketed with new 307 detector) �
- Astoria-Pacific SPOTCHECK Analyzer with NeoPac (Fluorometric and . Photometric Detection options, i.e. predicate detectors)
Introduction
The SPOTCHECK continuous flow analyzer consists of various devices that interact together to provide a complete in vitro diagnostic (IVD) instrument system for use with Astoria-Pacific's neonatal screening assays. The technology can be considered automated bench chemistry in which continuously flowing reagents are mixed with the sample, ultimately producing a detectable product that correlates to analyte concentration. Proper conditions for reactions are controlled by using a variety of techniques such as specific timing for reagent inputs, incubation at specific temperatures, and/or dialysis. Depending upon the particular IVD assay, system components may differ slightly. In each case however, a system consists of an autosampler, a pump for reagents and sample streams, a module where assay chemistry occurs, a detector (including flowcell), and an interface unit that facilitates communication with the software.
The software, device modification, and new device described herein do not propose to alter the FDA-cleared assays used on the instrument.
Indications for use
The devices described herein do not contain any one specific indication for use, nor does the complete generic system for which they are a part. Complete systems are used to screen for inborn errors of metabolism in neonatal patient dried blood spots. Indications for use (bold), and the respective Astoria-Pacific reagent kits available are provided below:
SPOTCHECK Flow options
- Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency . (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- Galactose and galactose-1-phosphate, elevated total galactose concentration . (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK . Phenylalanine 50 Hour Reagent Kit
- Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD . 50 Hour Reagent Kit
- Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 . Hour Reagent Kit
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SPOTCHECK Analyzer with NeoPac options
- Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency . (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit ●
- Galactose and galactose-1-phosphate, elevated total galactose concentration . (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- . Phenylalanine, elevated concentration (Phenylketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD . 50 Hour Reagent Kit
- Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 . Hour Reagent Kit
Proposed Modifications
The proposed modifications to the analyzer system components allow for 2 new unique system options; they are as follows:
-
- 350D Interface Unit: The predicate interface unit used for communications between detectors and software has been updated to accommodate the new software*.
OR
- 350D Interface Unit: The predicate interface unit used for communications between detectors and software has been updated to accommodate the new software*.
-
- 307 Digital Photometer/Fluorometer: A new detector has been developed as an alternative to using the interface unit and predicate fluorometric detector. It is intended to be used with the new software*.
AND
- 307 Digital Photometer/Fluorometer: A new detector has been developed as an alternative to using the interface unit and predicate fluorometric detector. It is intended to be used with the new software*.
*NeoPac: A new software package has been developed to replace outdated software. The 2 options listed above both depend on this software to complete the system.
Each new or modified component is briefly described below:
NeoPac Software
NeoPac is a newly developed software package designed to replace Astoria-Pacific's predicate software package. It is intended for use with new components and Microsoft® operating systems currently on the market. The software facilitates similar instrument controls as the predicate package, while adding minor but important functionality.
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INTERNATIONAL
350D Interface Unit
The 350D facilitates electronic communication between NeoPac software and the detector(s), autosampler and pump. Each unit has 7 analog detector inputs on the front panel, a power cord connection, and cable connections for a PC, autosampler and pump. Its sole purpose is to provide a mechanism for commands and data to flow to and from the software and system components. The 350D is modified from the predicate device (350 Interface Unit) in order to communicate with new software.
307 Digital Photometer/Fluorometer
The 307 detector is a newly developed detection platform intended to provide an alternative option to the interface unit and one or more detectors in the SPOTCHECK analyzer system. Aside from providing a state-of-the-art option for detection, its spatial requirements are significantly less than the predicate device. It can be manufactured with up to 4 unique photometric or fluorometric detection channels and an additional analog input (offering the ability to connect to a standalone detector). In conjunction with NeoPac software, it facilitates the communication of data and commands between a PC, autosampler and pump.
The 307 consists of a base module with up to 4 detection channels (not including a reference channel); each channel is either a fluorometer module or a photometric subassembly. The fluorometer module is a removable device that contains a flowcell, excitation LED, and emission bandpass filter. Each fluorometer module is manufactured according to the specifications of the assay it is intended to be used with. The photometric subassembly is not removable by the user.
The only significant differences between the 307 and the predicate detectors (321 and 315) are the use of LEDs for excitation (fluorometry) and a bandpass filter instead of a monochromator (photometry).
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INTERNATIONAL
| Device | ||||
|---|---|---|---|---|
| 510(k) | K101392 | K883020 | K851542 | |
| Original Name | n/a | RFA300 | RFA300 | |
| Current Name | SPOTCHECK Flow | SPOTCHECK Analyzer | SPOTCHECK | |
| Analyzer | ||||
| Software | NeoPac | FASPac | FASPac | |
| Interface Unit | None | 350 | 350 | |
| Detector | 307 | 321 | 315 | |
| Detection | ||||
| Method | Fluorometric (PMT) | Fluorometric (PMT) | Photometric | |
| (Monochromator) | ||||
| Light Source | Ex. wavelength LED | Quartz-halogen | Tungsten-halogen | |
| Other system | ||||
| components | ||||
| (e.g. sampler, | ||||
| pump, chemistry | ||||
| cartridges) | Same | Same | Same |
Comparison of Devices Mentioned in the Submission
5. Statement of Intended Use
The devices described herein are intended to be used with Astoria-Pacific's SPOTCHECK family of neonatal screening reagent kits. Assays currently offered on the system included Uridyltransferase (GALT), Biotinidase**, Total Galactose, Phenylalanine, G6PD, and Tyrosine. They are intended for use by qualified clinical laboratory professionals.
** Astoria-Pacific is not currently seeking FDA-clearance for Biotinidase on the SPOTCHECK Flow.
6. Device Comparison
EP9-A2 Study
The first study described below adhered to the protocol outlined in Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Second Edition, EP9-A2. The new system option including the 307 detector was directly compared against the appropriate detector (321 Fluorometer) for 5 neonatal screening assays currently on the market. Results are summarized in the table Method Comparison and Bias Essimation Using New 307 Detector.
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I N T E R N A T I O N A L
Dried blood spots were obtained to represented both normal and deficient conditions for each of the 5 individual assays used on the SPOTCHECK system. Since patient samples with deficient and partially-deficient conditions are rare and especially difficult to obtain, in some cases dried blood spot controls provided by different manufacturers (including Astoria-Pacific and the Centers for Disease Control) were used to ensure adequate sample distribution across the assay range. Samples tested include responses around the medical decision levels for each individual assay. These levels were chosen using the cut-offs established in Astoria-Pacific's quality control laboratory.
The results of the EP9-A2 protocol demonstrate that there is no clinically-significant bias which would suggest a need for further analysis. The fluorometric assays performed nearly identical on both the 307 and predicate detector. Since the detection paradigms on the 307 are equivalent to the predicate device, the strong agreement was anticipated.
| Method Comparison and Bias Estimation Using New 307 Detector | |||||
|---|---|---|---|---|---|
| SPOTCHECK Assay Tested | |||||
| Parameter | Total | ||||
| Galactose | UT (GALT) | Phenylalanine | G6PD | Tyrosine | |
| Units | mg/dl | µM NADH | mg/dl | µM NADH | mg/dl |
| Linear Regression | |||||
| slope (m), intercept (b) | m = 1.02 | ||||
| b = -0.58 | m = 0.96 | ||||
| b = -1.49 | m = 1.01 | ||||
| b = -0.02 | m = 1.00 | ||||
| b = -1.24 | m = 1.01 | ||||
| b = -0.05 | |||||
| Correlation Coefficient, R² | 1.00 | 0.99 | 1.00 | 1.00 | 1.00 |
| Number of Samples (N) | 69 | 58 | 70 | 60 | 71 |
| Replicates per Sample | 2 | 2 | 2 | 2 | 2 |
| Medical Decision Level, Xc | 10 | 60 | 4 | 40 | 4 |
| Bias at Xc | -0.3 | -3.8 | 0.02 | -1.1 | 0.01 |
| 95% Confidence Interval | |||||
| of Bias at Xc | 9.6 to 9.7 | 55 to 57 | 4.0 to 4.0 | 39 to 39 | 4.0 to 4.0 |
| Acceptable Bias | |||||
| Near Xc | 9.4 to 10.6 | 56 to 64 | 3.7 to 4.3 | 37 to 43 | 3.8 to 4.2 |
Additional Study of Newborn Specimens
A second comparison study for each assay (Uridyltransferase (GALT), Total Galactose, Phenylalanine, and Tyrosine) was performed using a minimum of 88 newborn dried blood spots obtained from domestic newborn screening laboratories. The new G6PD study involved 50 newborn specimens, however the original study (described above) utilized a significant number of newborn specimens. The results of the G6PD study include 42 measurements from the previous study.
6
I T E R N A T I O N A L
| Assay | N = | No. of
Newborns | Slope | 95%
Confidence
(Upper, Lower) | Intercept | 95%
Confidence
(Upper, Lower) | R² |
|-----------------|-----|--------------------|-------|-------------------------------------|-----------|-------------------------------------|------|
| Total Galactose | 112 | 96 | 0.99 | 0.98, 1.01 | -0.83 | -0.73, -0.93 | 0.99 |
| Phenylalanine | 112 | 96 | 0.99 | 0.98, 0.99 | 0.01 | 0.0, 0.02 | 1.00 |
| Tyrosine | 101 | 88 | 0.99 | 0.98, 0.99 | 0.01 | 0.0, 0.02 | 1.00 |
| UT (GALT) | 96 | 94 | 1.03 | 1.00, 1.07 | -7.6 | -3.3, -12.0 | 0.97 |
| G6PD | 92 | 92 | 0.97 | 0.96, 0.98 | -0.56 | -1.4, 0.28 | 1.00 |
The results from the second study closely match the original study and no clinically significant bias between detection paradigms was observed.
Sensitivity
Evaluation of TGal, Phe, Tvr. and G6PD utilized 3 low-level samples analyzed over 3 days in batches of 20 low-level replicates and 20 blank replicates per run (for each method). Evaluation of GALT utilized 2 low-level samples analyzed over 3 days in batches of 20 low-level replicates and 20 blank replicates per run (1 low level sample was used in 2 of 3 runs, 40 replicates in total). Results were used to determine the sensitivity of the analytical system for each method. The study was conducted according to CLSI EP17-A: Protocols for Determination of Limits of Detection and Limits of Quantitation; Approved Guideline. The study results demonstrated equivalent or improved sensitivity performance when compared to the predicate system. A summary is provided below.
| 307/NeoPac LoD | Predicate Device LoD | |
|---|---|---|
| TGal | 0.2 mg/dl | 0.3 mg/dl |
| Phe | 0.1 mg/dl | 0.2 mg/dl |
| Tyr | 0.2 mg/dl | 0.2 mg/dl |
| GALT | 3 µM NADPH | 5 µM NADPH |
| G6PD | 1 µM NADPH | 2 µM NADPH |
Precision
Evaluation of precision for TGal, Phe, Tyr and GALT utilized 3 samples at different levels of activity or concentration (generally: low, medium, and high) for each method tested. Samples were analyzed over 5 days, 1 run per day, 8 replicates of each sample per run. Sample order was changed for each run.
7
I N T E R N A T I O N A L
Evaluation of precision for G6PD also utilized 3 samples at low, medium and high activity, however, samples were analyzed over 4 days with 1 run per day for 3 days and 2 runs on one day. Eight replicates of each sample were analyzed per run in order to attain the degrees of freedom recommended in the protocol. Sample order was the same for each run. The study was conducted according to CLSI EP5-A2: Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline – Second Edition.
Each method's results demonstrated an improvement in precision over the predicate device at comparable levels of analyte/enzyme activity. The only exception is an observed increase in imprecision at very low levels of G6PD enzyme activity, however, said imprecision is acceptable and not clinically significant. Neither within-run nor total precision suggests that a neonate with deficient G6PD activity would be qualified as normal, especially considering the comparable precision around the clinical decision level.
| TGal - 307/NeoPac | Normal | Near Cutoff | Galactosemic |
|---|---|---|---|
| n (# of observations) | 40 | 40 | 40 |
| Mean (mg/dL) | 6.2 | 11.3 | 31.4 |
| Sr (within-run precision) | 0.051 | 0.118 | 0.168 |
| C.V. (within-run) | 0.82 | 1.05 | 0.53 |
| B (daily mean precision) | 0.208 | 0.144 | 0.609 |
| ST (total precision) | 0.214 | 0.181 | 0.629 |
| %C.V. (total) | 3.4 | 1.6 | 2.0 |
| TGal - Predicate Device | Normal | Normal | Galactosemic |
|---|---|---|---|
| n (# of observations) | 20 | 20 | 20 |
| Mean (mg/dL) | 7.75 | 5.82 | 29.3 |
| Sr (within-run precision) | 0.340 | ||
| C.V. (within-run) | 4.30 | ||
| ST (total precision) | 0.60 | 2.20 | |
| %C.V. (total) | 10.3 | 7.5 |
NOTE: Cells in gray signify unavailable data for the predicate device.
| Phe - 307/NeoPac | Normal | Near Cutoff | Elevated |
|---|---|---|---|
| n (# of observations) | 40 | 40 | 40 |
| Mean (mg/dL) | 2.0 | 4.5 | 15.3 |
| Sr (within-run precision) | 0.014 | 0.028 | 0.065 |
| C.V. (within-run) | 0.70 | 0.63 | 0.42 |
| B (daily mean precision) | 0.064 | 0.099 | 0.152 |
| ST (total precision) | 0.065 | 0.102 | 0.163 |
| %C.V. (total) | 3.3 | 2.3 | 1.1 |
8
N T E R N A T I O N A L
Precision results (continued)
| Phe – Predicate Device | Normal | Near Cutoff | Elevated |
|---|---|---|---|
| n (# of observations) | 20 | 20 | 20 |
| Mean (mg/dL) | 2.89 | 5 | 9.99 |
| St (within-run precision) | 0.210 | ||
| C.V. (within-run) | 4.20 | ||
| ST (total precision) | 0.27 | 0.86 | |
| %C.V. (total) | 9.4 | 8.6 |
| Tyr - 307/NeoPac | Normal | Near Cutoff | Tyrosinemic |
|---|---|---|---|
| n (# of observations) | 40 | 40 | 40 |
| Mean (mg/dL) | 1.8 | 7.7 | 18.5 |
| S , (within-run precision) | 0.036 | 0.061 | 0.177 |
| C.V. (within-run) | 1.99 | 0.79 | 0.96 |
| B (daily mean precision) | 0.070 | 0.178 | 0.762 |
| S T (total precision) | 0.078 | 0.187 | 0.780 |
| %C.V. (total) | 4.3 | 2.4 | 4.2 |
| Tyr - Predicate Device | Near Cutoff | Near Cutoff |
|---|---|---|
| n (# of observations) | 30 | 30 |
| Mean (mg/dL) | 6.04 | 8.52 |
| Sᵢ (within-run precision) | 0.10 | 0.35 |
| C.V. (within-run) | 1.60 | 4.10 |
| Sₜ (total precision) | 0.16 | 0.42 |
| %C.V. (total) | 2.8 | 5.0 |
| GALT - 307/NeoPac | Galactosemic | Carrier | Normal |
|---|---|---|---|
| n (# of observations) | 40 | 40 | 40 |
| Mean (µM NADPH) | 6.6 | 62.5 | 122.0 |
| Sₜ (within-run precision) | 0.34 | 1.05 | 1.21 |
| C.V. (within-run) | 5.18 | 1.67 | 0.99 |
| B (daily mean precision) | 0.28 | 2.68 | 4.37 |
| Sₜ (total precision) | 0.43 | 2.86 | 4.51 |
| %C.V. (total) | 6.5 | 4.6 | 3.7 |
| GALT - Predicate Device | Near Cutoff | Normal |
|---|---|---|
| n (# of observations) | 96 | 58 |
| Mean (µM NADPH) | 30 | 235 |
| St (within-run precision) | 2.95 | 12.60 |
| C.V. (within-run) | 9.9 | 5.3 |
| St (total precision) | 3.7 | 13.0 |
| %C.V. (total) | 13 | 5.5 |
9
I N T E R N A T I O N A L
| G6PD - 307/NeoPac | Deficient | Near Cutoff | Normal |
|---|---|---|---|
| n (# of observations) | 40 | 40 | 40 |
| Mean (µM NADPH) | 3.4 | 39.7 | 83.1 |
| Sr (within-run precision) | 0.28 | 0.53 | 1.18 |
| C.V. (within-run) | 8.15 | 1.33 | 1.42 |
| B (daily mean precision) | 0.15 | 1.98 | 5.29 |
| ST (total precision) | 0.30 | 2.04 | 5.40 |
| %C.V. (total) | 8.7 | 5.1 | 6.5 |
| G6PD - Predicate Device | Deficient | Near Cutoff | Normal |
| n (# of observations) | 16 | 16 | 16 |
| Mean (µM NADPH) | 7.8 | 43 | 158 |
| Sr (within-run precision) | 0.25 | 1.9 | 4.9 |
| C.V. (within-run) | 3.2 | 4.4 | 3.1 |
| ST (total precision) | 0.4 | 2.6 | 13.7 |
| %C.V. (total) | 5.4 | 6.0 | 8.7 |
Precision results (continued)
7. Overall Conclusion
Device comparison for the assays of interest demonstrates strong agreement. Astoria-Pacific concludes that the new system options are safe and effective, and equivalent to the predicate devices.
10
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or bird in flight, depicted with stylized lines.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
FEB 0 4 2011
Astoria-Pacific, Inc. c/o Jason Reynolds Director of Research and Development 15130 S.E. 82" Drive Clackamas. OR 97015
Re: K101392
Trade/Device Name: Astoria-Pacific SPOTCHECK Flow, Astoria-Pacific SPOTCHECK Analyzer with NeoPac, Fluorometer and Photometer, Astoria-Pacific SPOTCHECK Analyzer with NeoPac and Photometer, Astoria-Pacific SPOTCHECK Analyzer with NeoPac and Fluorometer Regulation Number: 21 CFR § 862.1315 Regulation Name: Galactose-1-phosphate uridyl transferase test system Regulatory Class: Class II Product Code: KQP, JIA, JNB, JBL, CDR, NAK, JJC Dated: December 29, 2010 Received: December 30, 2010
Dear Mr. Reynolds:
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 device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
11
Page 2 –
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation on Safety at (01) 796-5450. 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 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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
C.C.
Courtney 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
12
510(k): K101392
Device Name: Astoria-Pacific SPOTCHECK® Flow™
Indications For Use:
The SPOTCHECK Flow system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:
- Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency . (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- . Galactose and galactose-1-phosphate, elevated total galactose concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- Phenylalanine, elevated concentration (Phenylketonuria); . SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK . G6PD 50 Hour Reagent Kit
- Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK . Tyrosine 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 17
13
510(k): K101392
Astoria-Pacific SPOTCHECK® Analyzer with NeoPac™, Fluorometer Device Name: and Photometer
Indications For Use:
The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:
- . Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour . Reagent Kit
- Galactose and galactose-1-phosphate, elevated total galactose . concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- Phenylalanine, elevated concentration (Phenvlketonuria); . SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK . G6PD 50 Hour Reagent Kit
- Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK . Tyrosine 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
X Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
Page 2 of 4
14
510(k): K101392
Astoria-Pacific SPOTCHECK® Analyzer with NeoPac™ and Device Name: Photometer
Indications For Use:
The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn error in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assay are:
- . Biotinidase enzyme deficiency; SPOTCHECK Biotinidase 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
X Prescription Use_ (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use .... : (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
Page 3 of 4
15
510(k): K101392
Astoria-Pacific SPOTCHECK® Analyzer with NeoPac™ and Device Name: Fluorometer
Indications For Use:
The SPOTCHECK Analyzer system is used for in vitro diagnostic newborn screening in conjunction with Astoria-Pacific's SPOTCHECK family of reagent kits. The specific inborn errors in metabolism screened for (bold), and the respective Astoria-Pacific dried blood spot assays are:
- . Galactose-1-phosphate uridyltransferase (GALT) enzyme deficiency (Galactosemia); SPOTCHECK UridyItransferase 50 Hour Reagent Kit
- Galactose and galactose-1-phosphate, elevated total galactose . concentration (Galactosemia); SPOTCHECK Total Galactose 50 Hour Reagent Kit
- . Phenylalanine, elevated concentration (Phenviketonuria); SPOTCHECK Phenylalanine 50 Hour Reagent Kit
- . Glucose-6-phosphate dehydrogenase enzyme deficiency; SPOTCHECK G6PD 50 Hour Reagent Kit
- . Tyrosine, elevated concentration (Tyrosinemia); SPOTCHECK Tyrosine 50 Hour Reagent Kit
The system is intended for screening use only and is not intended for monitoring purposes.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carl Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
Page 4 of 4