(116 days)
AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine.
Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.
AMY7 reagent is used to measure the amylase activity by an enzymatic rate method. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the activity of AMY7 in the sample and is used by the System to calculate and express the total AMY7 activity.
The SYNCHRON G7 Amylase (AMY7) Reagent is designed for optimal performance on the SYNCHRON LX®, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges.
Acceptance Criteria and Device Performance for SYNCHRON® Systems G7 Amylase (AMY7) Reagent
This document describes the acceptance criteria and study proving the SYNCHRON® Systems G7 Amylase (AMY7) Reagent meets these criteria, based on the provided FDA 510(k) submission (K091846).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" with numerical thresholds. Instead, it demonstrates substantial equivalence to a predicate device through various performance studies. The implicit acceptance criterion is that the candidate device's performance should be comparable to or better than the predicate device across critical metrics.
Based on the summary of performance data, the following table outlines the reported device performance for different studies. The "Acceptance Criteria" column reflects the implicit expectation for a new device to perform comparably to or better than the predicate.
| Study Type | Device Performance (SYNCHRON G7 Amylase) | Implicit Acceptance Criteria (relative to Predicate) |
|---|---|---|
| Method Comparison (Serum) | ||
| CX7 PRO | Slope: 1.150, Intercept: -4.089, R: 0.9999 (N=87) | High correlation (R close to 1.0), slope close to 1.0, intercept close to 0 |
| DxC 600 | Slope: 1.081, Intercept: -3.364, R: 1.0000 (N=83) | High correlation (R close to 1.0), slope close to 1.0, intercept close to 0 |
| Method Comparison (Urine) | ||
| CX7 PRO | Slope: 1.109, Intercept: -2.086, R: 0.9997 (N=78) | High correlation (R close to 1.0), slope close to 1.0, intercept close to 0 |
| DxC 600 | Slope: 1.039, Intercept: -0.703, R: 0.9997 (N=78) | High correlation (R close to 1.0), slope close to 1.0, intercept close to 0 |
| Precision (CX7 PRO) | ||
| Within-Run Serum/Plasma Level 1 | Mean: 75.8 U/L, SD: 1.3 U/L, %CV: 1.7 (N=80) | Low %CV for within-run precision |
| Within-Run Serum/Plasma Level 2 | Mean: 899.5 U/L, SD: 4.7 U/L, %CV: 0.5 (N=80) | Low %CV for within-run precision |
| Within-Run Serum/Plasma ORDAC | Mean: 1762.0 U/L, SD: 12.9 U/L, %CV: 0.7 (N=80) | Low %CV for within-run precision |
| Within-Run Urine Level 1 | Mean: 54.9 U/L, SD: 1.3 U/L, %CV: 2.4 (N=80) | Low %CV for within-run precision |
| Within-Run Urine Level 2 | Mean: 164.6 U/L, SD: 1.7 U/L, %CV: 1.1 (N=80) | Low %CV for within-run precision |
| Within-Run Urine ORDAC | Mean: 1182.9 U/L, SD: 11.8 U/L, %CV: 1.0 (N=80) | Low %CV for within-run precision |
| Total Imprecision Serum/Plasma Level 1 | Mean: 75.8 U/L, SD: 1.4 U/L, %CV: 1.8 (N=80) | Low %CV for total imprecision |
| Total Imprecision Serum/Plasma Level 2 | Mean: 899.5 U/L, SD: 8.2 U/L, %CV: 0.9 (N=80) | Low %CV for total imprecision |
| Total Imprecision Serum/Plasma ORDAC | Mean: 1762.0 U/L, SD: 34.9 U/L, %CV: 2.0 (N=80) | Low %CV for total imprecision |
| Total Imprecision Urine Level 1 | Mean: 54.9 U/L, SD: 1.4 U/L, %CV: 2.5 (N=80) | Low %CV for total imprecision |
| Total Imprecision Urine Level 2 | Mean: 164.6 U/L, SD: 1.9 U/L, %CV: 1.2 (N=80) | Low %CV for total imprecision |
| Total Imprecision Urine ORDAC | Mean: 1182.9 U/L, SD: 60.4 U/L, %CV: 5.1 (N=80) | Low %CV for total imprecision |
| Precision (UniCel DxC 600) | ||
| Within-Run Serum/Plasma Level 1 | Mean: 78.7 U/L, SD: 1.0 U/L, %CV: 1.3 (N=80) | Low %CV for within-run precision |
| Within-Run Serum/Plasma Level 2 | Mean: 913.6 U/L, SD: 4.5 U/L, %CV: 0.5 (N=80) | Low %CV for within-run precision |
| Within-Run Serum/Plasma ORDAC | Mean: 1775.4 U/L, SD: 8.7 U/L, %CV: 0.5 (N=80) | Low %CV for within-run precision |
| Within-Run Urine Level 1 | Mean: 56.5 U/L, SD: 0.7 U/L, %CV: 1.2 (N=80) | Low %CV for within-run precision |
| Within-Run Urine Level 2 | Mean: 168.4 U/L, SD: 0.9 U/L, %CV: 0.5 (N=80) | Low %CV for within-run precision |
| Within-Run Urine ORDAC | Mean: 1181.0 U/L, SD: 6.0 U/L, %CV: 0.5 (N=80) | Low %CV for within-run precision |
| Total Imprecision Serum/Plasma Level 1 | Mean: 78.7 U/L, SD: 0.8 U/L, %CV: 1.1 (N=80) | Low %CV for total imprecision |
| Total Imprecision Serum/Plasma Level 2 | Mean: 913.6 U/L, SD: 5.5 U/L, %CV: 0.6 (N=80) | Low %CV for total imprecision |
| Total Imprecision Serum/Plasma ORDAC | Mean: 1775.4 U/L, SD: 11.0 U/L, %CV: 0.6 (N=80) | Low %CV for total imprecision |
| Total Imprecision Urine Level 1 | Mean: 56.5 U/L, SD: 0.7 U/L, %CV: 1.2 (N=80) | Low %CV for total imprecision |
| Total Imprecision Urine Level 2 | Mean: 168.4 U/L, SD: 1.1 U/L, %CV: 0.7 (N=80) | Low %CV for total imprecision |
| Total Imprecision Urine ORDAC | Mean: 1181.0 U/L, SD: 55.5 U/L, %CV: 4.7 (N=80) | Low %CV for total imprecision |
The study details that "Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments." The provided results for method comparison and precision support this claim by showing strong correlation coefficients and low coefficients of variation, indicating the device performs comparably to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
The document refers to "test sets" in the context of method comparison and precision studies.
- Method Comparison Studies (Test Set Sample Sizes):
- Serum: N=87 (on CX7 PRO), N=83 (on DxC 600)
- Urine: N=78 (on CX7 PRO), N=78 (on DxC 600)
- Precision Studies (Test Set and Measurement Sample Sizes):
- Each of the 12 precision measurements (e.g., Within-Run Serum/Plasma Level 1 on CX7 PRO) was based on N=80 measurements. This means 80 individual readings or replicates were taken for each specific sample level/type/imprecision category on each platform.
- Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable to this type of device. The SYNCHRON® Systems G7 Amylase (AMY7) Reagent is an in-vitro diagnostic assay for quantitative determination of amylase activity. The "ground truth" for such devices is typically established by comparing its measurements against a legally marketed predicate device (as done here) or against a recognized reference method, rather than through expert consensus on qualitative interpretation (like in imaging diagnostics). Therefore, no human experts were involved in establishing the ground truth for the test set in the way described.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. No human adjudication was involved as the ground truth is based on quantitative measurements and comparison to a predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This section is not applicable. This device is an automated in-vitro diagnostic reagent and does not involve "human readers" or "AI assistance" in the context of interpretation or a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This describes the nature of the device: it is a standalone automated assay. The performance data presented (method comparison, precision) reflects the algorithm's (reagent's) performance without human intervention in the measurement process after sample loading. The results are generated directly by the SYNCHRON® System(s) and UniCel® DxC System(s).
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device is established by comparison to a legally marketed predicate device (Thermo Fisher Scientific, Inc. Amylase EPS Reagent, K070064) using method comparison studies. This type of comparison demonstrates that the new device provides results that are substantially equivalent to a device already cleared by the FDA, implying that its measurements are generally accepted as accurate and reliable for the intended use. In addition, the device's inherent precision (reproducibility of results) is also assessed and forms part of its validated performance.
8. The Sample Size for the Training Set
The document does not provide details about a "training set" in the context of machine learning or AI models. For an IVD reagent, development and validation typically involve:
- Reagent formulation and optimization: This involves experiments to define the optimal concentrations of components, reaction times, etc., using various samples, analogous to a training phase by trial and error in product development.
- Verification studies (linearity, interference, etc.): These use various prepared samples to ensure the assay performs as expected.
- Validation studies (method comparison, precision, stability): These studies, as detailed in the document, use human biological samples to demonstrate performance against established methods.
The document directly presents validation study results. It does not separate data into distinct "training" and "test" sets in the machine learning sense, as the device is a chemical reagent, not an AI model.
9. How the Ground Truth for the Training Set Was Established
As noted in section 8, the concept of a "training set" with an associated ground truth in the AI context is not directly applicable here. The development and optimization of the reagent formulation implicitly involves establishing what constitutes an accurate amylase measurement (i.e., "ground truth") often through comparison to known standards, reference methods, or existing predicate devices during the development phase. However, the document does not detail this initial development process. The "ground truth" for the validation specified in this document is the performance of the predicate device.
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Summary of Safety & Effectiveness SYNCHRON® Systems G7 Amylase (AMY7) Reagent
1.0 Submitted By:
Marine Boyajian Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: (714) 961-6536 FAX: (714) 961-4234
OCT 1 6 2009
2.0 Date Submitted:
June 19, 2009
3.0 Device Name(s):
3.1 Proprietary Names SYNCHRON® Systems G7 Amylase (AMY7) Reagent
3.2 Classification Name
Amylase test system (21 CFR § 862.1070)
4.0 Predicate Device :
| Candidate(s) | Predicate | Manufacturer | DocketNumber |
|---|---|---|---|
| SYNCHRON Systems G7Amylase (AMY7) Reagent | Amylase EPS Reagent | Thermo FisherScientific, Inc. | K070064 |
5.0 Description:
AMY7 reagent is used to measure the amylase activity by an enzymatic rate method. The system monitors the change in absorbance at 410 nanometers. This change in absorbance is directly proportional to the activity of AMY7 in the sample and is used by the System to calculate and express the total AMY7 activity.
The SYNCHRON G7 Amylase (AMY7) Reagent is designed for optimal performance on the SYNCHRON LX®, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges.
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Ko 91846
page 2 of 4
6.0 Intended Use:
AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine.
Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicate identified in Section 4.0 of this summary and the G7 Amylase (AMY7) Reagent.
| Similarities | |||
|---|---|---|---|
| SYNCHRONSystems G7Amylase(AMY7)Reagent | Intended Use | Same | |
| Sample Types | Same | ||
| Instrument Platforms | Same | ||
| Primary DetectionWavelength | Same | ||
| Reaction Type(Methodology) | Same | ||
| Reagent Volume | AMY7 Reagent: Compartment A: 175 µlCompartment B: 35 µlEPS-G7 Reagent: Compartment A: 175 µlCompartment B: 35 µl | ||
| Differences | |||
| SYNCHRONSystems G7Amylase(AMY7)Reagent | Analytical range(Serum/Plasma/ Urine) | AMY7 Reagent: 8 – 1200 U/L on CX PRO5 – 1200 U/L on LX/DxC1000 – 2000 U/L ORDACEPS-G7 Reagent: 4 – 1800 U/L on CX4 – 2000 U/L on LX/DxC | |
| Open reagent stability | AMY7 Reagent: 21 daysEPS-G7 Reagent: 35 days | ||
| Sample volume | AMY7 Reagent: 7 µl3 µl ORDACEPS-G7 Reagent: 7 µl |
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8.0 Summary of Performance Data:
The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.
| Candidate | Platform | Slope | Intercept | R | N | PredicateMethod |
|---|---|---|---|---|---|---|
| G7 Amylase(AMY7) Reagent | CX7 PRO | 1.150 | -4.089 | 0.9999 | 87 | Thermo FisherAmylase EPS - |
| DxC 600 | 1.081 | -3.364 | 1.0000 | 83 | G7 Reagent |
Serum Method Comparison Summary
Urine Method Comparison Summary
| Candidate | Platform | Slope | Intercept | R | N | PredicateMethod |
|---|---|---|---|---|---|---|
| G7 Amylase(AMY7) Reagent | CX7 PRO | 1.109 | -2.086 | 0.9997 | 78 | Thermo Fisher |
| DxC 600 | 1.039 | -0.703 | 0.9997 | 78 | Amylase EPS –G7 Reagent |
. . . . . . . . . . . . . . . . . . . . . . . . . . . .
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SYNCHRON Systems G7 Amylase (AMY7) Reagent Precision Study Results
| Sample | Mean(U/L) | S.D.(U/L) | %C.V. | N | |
|---|---|---|---|---|---|
| Within-Run Imprecision | |||||
| Serum/Plasma | Level 1 | 75.8 | 1.3 | 1.7 | 80 |
| Serum/Plasma | Level 2 | 899.5 | 4.7 | 0.5 | 80 |
| Serum/Plasma | (ORDAC) | 1762.0 | 12.9 | 0.7 | 80 |
| Urine | Level 1 | 54.9 | 1.3 | 2.4 | 80 |
| Urine | Level 2 | 164.6 | 1.7 | 1.1 | 80 |
| Urine | (ORDAC) | 1182.9 | 11.8 | 1.0 | 80 |
| Total Imprecision | |||||
| Serum/Plasma | Level 1 | 75.8 | 1.4 | 1.8 | 80 |
| Serum/Plasma | Level 2 | 899.5 | 8.2 | 0.9 | 80 |
| Serum/Plasma | (ORDAC) | 1762.0 | 34.9 | 2.0 | 80 |
| Urine | Level 1 | 54.9 | 1.4 | 2.5 | 80 |
| Urine | Level 2 | 164.6 | 1.9 | 1.2 | 80 |
| Urine | (ORDAC) | 1182.9 | 60.4 | 5.1 | 80 |
Precision Study Results on SYNCHRON CX7 PRO Clinical System
Precision Study Results on UniCel DxC 600 SYNCHRON Clinical System
| Sample | Mean(U/L) | S.D.(U/L) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Serum/Plasma Level 1 | 78.7 | 1.0 | 1.3 | 80 |
| Serum/Plasma Level 2 | 913.6 | 4.5 | 0.5 | 80 |
| Serum/Plasma (ORDAC) | 1775.4 | 8.7 | 0.5 | 80 |
| Urine Level 1 | 56.5 | 0.7 | 1.2 | 80 |
| Urine Level 2 | 168.4 | 0.9 | 0.5 | 80 |
| Urine (ORDAC) | 1181.0 | 6.0 | 0.5 | 80 |
| Total Imprecision | ||||
| Serum/Plasma Level 1 | 78.7 | 0.8 | 1.1 | 80 |
| Serum/Plasma Level 2 | 913.6 | 5.5 | 0.6 | 80 |
| Serum/Plasma (ORDAC) | 1775.4 | 11.0 | 0.6 | 80 |
| Urine Level 1 | 56.5 | 0.7 | 1.2 | 80 |
| Urine Level 2 | 168.4 | 1.1 | 0.7 | 80 |
| Urine (ORDAC) | 1181.0 | 55.5 | 4.7 | 80 |
This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CF R 807.92.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Beckman Coulter. Inc. ATTN: Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200 South Kraemer Blvd. W-110 Brea, CA 92822
OCT 1 & 2009
Re: K091846
Trade/Device Name: Synchron® Systems G7 Amylase (AMY7) Reagent Regulation Number: 21 CFR §862.1070 Regulation Name: Amylase test system. Regulatory Class: Class II Product Code: JFJ Dated: September 11, 2009 Received: September 14, 2009
Dear Ms. Boyajian:
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 (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).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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 premarket notification" (21 CFR Part 807.97). For questions 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 vours.
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
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Indication for Use
510(k) Number: K091846
Device Name: SYNCHRON® Systems G7 Amylase (AMY7) Reagent
Indication For Use:
AMY7 reagent, in conjunction with SYNCHRON® System(s) and UniCel® DxC System(s), is intended for the quantitative determination of total Amylase activity in human serum, plasma or urine.
Amylase measurements are used primarily in the diagnosis and treatment of pancreatitis.
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 (OIVD)
y
Diyision Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091846
Page 1 of 1
§ 862.1070 Amylase test system.
(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.