(84 days)
Not Found
No
The summary describes a chemical reagent and its use with standard clinical chemistry analyzers for quantitative determination of lipase activity. There is no mention of AI, ML, image processing, or any data-driven algorithms beyond standard analytical calculations.
No
The device is an in-vitro diagnostic reagent used to measure pancreatic lipase activity to aid in the diagnosis and treatment of pancreatic diseases. It does not directly treat or prevent a disease, which is the definition of a therapeutic device.
Yes
The device is described as being for "quantitative determination of pancreatic lipase activity" and "Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct," which indicates its use in the diagnostic process.
No
The device is a reagent (chemical substance) intended for use with clinical chemistry analyzers, which are hardware devices. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of pancreatic lipase activity in serum or plasma samples." This involves testing biological samples outside of the body.
- Device Description: The description reinforces that it's an "assay" designed for use with "clinical chemistry analyzers," which are instruments used for in vitro testing of biological fluids.
- Purpose: The description mentions that "Lipase measurements are used in diagnosis and treatment of diseases of the pancreas." This indicates a medical purpose related to diagnosis, which is a key characteristic of IVDs.
- Sample Type: It specifies the use of "serum or plasma samples," which are biological specimens.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
N/A
Intended Use / Indications for Use
The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
Product codes (comma separated list FDA assigned to the subject device)
CHI, JIT
Device Description
This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® AND LX™ Clinical Systems. The SYNCHRON Systems Lipase (LIPA) Reagent, when used in coniunction with SYCNRHON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pancreas
Indicated Patient Age Range
Not Found
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)
The data in the Premarket Notification supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. A summary of the data follows:
Method Comparison
Reagent: SYNCHRON Systems Lipase Reagent on the LX System
Slope: 1.068
Intercept (U/L): -0.42
r: 0.997
n: 91
Predicate Method: SYNCHRON Systems Lipase Reagent on the CX System
Measuring Range
Sample Type: serum
Measuring Option: default
Measuring Range: 5 - 600 U/L
Assessment: linear
Sample Type: serum
Measuring Option: ORDAC
Measuring Range: 480 - 1200 U/L
Assessment: linear
Imprecision
Within-Run Imprecision
Sample: Level 1
Mean (U/L): 109.53
S.D. (U/L): 1.51
%C.V.: 1.38
n: 80
Sample: Level 2
Mean (U/L): 269.80
S.D. (U/L): 4.15
%C.V.: 1.54
n: 80
Sample: Level 3
Mean (U/L): 16.33
S.D. (U/L): 1.17
%C.V.: 7.18
n: 80
Total Imprecision
Sample: Level 1
Mean (U/L): 109.53
S.D. (U/L): 2.50
%C.V.: 2.28
n: 80
Sample: Level 2
Mean (U/L): 269.80
S.D. (U/L): 6.03
%C.V.: 2.24
n: 80
Sample: Level 3
Mean (U/L): 16.33
S.D. (U/L): 1.59
%C.V.: 9.77
n: 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1465 Lipase test system.
(a)
Identification. A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
Beckman Instruments, Section 510(k) Notification SYNCHRON Systems Lipase Reagent Summary of Safety and Effectiveness
-
- Submitted by:
Sheri Hall Product Submissions Manager Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8916, FAX (714) 961-4457
- Submitted by:
JUN - 4 1997
-
- Date Submitted:
3 March 1997
- Date Submitted:
-
- Device Name(s):
SYNCHRON® Systems Lipase (LIPA) Reagent Lipase test system (21 CFR 862.1465)
- Device Name(s):
4. Predicate Device(s):
| Predicate | Predicate Company | Docket Number | |
|---|---|---|---|
| SYNCHRON CX | |||
| Systems Lipase | |||
| (LIPA) Reagent | Genzyme Lipase | ||
| Reagent | Toyo Jozo Co., Ltd | ||
| (Japan) | K952180 | ||
| SYNCHRON LX | |||
| Clinical System | SYNCHRON CX | ||
| Clinical System | Beckman | ||
| Instruments, Inc. | K965240 |
5. Description:
This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® AND LX™ Clinical Systems. The SYNCHRON Systems Lipase (LIPA) Reagent, when used in coniunction with SYCNRHON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.
6. Intended Use:
ﻤ ﻌﻠﻢ ﻭ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﻘﺎﺑﻠﺔ ﺍﻟﻤﻘﺎﺑ
The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYCNHRON Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYCNRHON CX and LX Clinical Systems.
7. Comparison to the Predicate:
The SYNCHRON Systems Lipase (LIPA) Reagent is similar to the predicate in the intended use, chemical reaction, reagent components and packaging, measurement method, default measuring range, and calibration method. They differ in the SYCNHRON Systems Lipase Reagent uses the system ORDAC (over range detection and correction) feature to expand the measuring range to 1200 U/L.
1
Beckman Instruments, Section 510(k) Notification SYNCHRON Systems Lipase Reagent Summary of Safety and Effectiveness
8. Summary of Performance Data:
ーーーーーーーーーーーーー
The data in the Premarket Notification supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. A summary of the data follows:
| Reagent | Slope | Intercept (U/L) | r | n | Predicate Method |
|---|---|---|---|---|---|
| SYNCHRON Systems | |||||
| Lipase Reagent on the | |||||
| LX System | 1.068 | -0.42 | 0.997 | 91 | SYNCHRON Systems |
| Lipase Reagent on the | |||||
| CX System |
| Sample Type | Measuring Option | Measuring Range | Assessment |
|---|---|---|---|
| serum | default | 5 - 600 U/L | linear |
| ORDAC | 480 - 1200 U/L | linear |
| Imprecision | ||||
|---|---|---|---|---|
| Sample | Mean | |||
| (U/L) | S.D. | |||
| (U/L) | %C.V. | n | ||
| Within-Run Imprecision | ||||
| Level 1 | 109.53 | 1.51 | 1.38 | 80 |
| Level 2 | 269.80 | 4.15 | 1.54 | 80 |
| Level 3 | 16.33 | 1.17 | 7.18 | 80 |
| Total Imprecision | ||||
| Level 1 | 109.53 | 2.50 | 2.28 | 80 |
| Level 2 | 269.80 | 6.03 | 2.24 | 80 |
| Level 3 | 16.33 | 1.59 | 9.77 | 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 CFR 807.92.
Method Comparison
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with its wings outstretched.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 4 1997
Sheri Hall Manager, Premarket Regulatory Beckman Instruments, Inc. 200 S. Kraemer Boulevard, M/S W-337 P.O. Box 8000 92822-8000 Brea, California
14
K970905 Re: SYNCHRON® Systems Lipase (LIPA) Reagent Requlatory Class: II Product Code: CHI, JIT Dated: April 28, 1997 Received: May 2, 1997
Dear Ms. Hall:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addicion, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to beqin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
page 1 of 1
510(k) Number (if known):
SYNCHRON® Systems Device Name: Lipase (LIPA) Reagent
Indications for Use:
The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the quantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.
21 CFR § 862.1465 Lipase Test System
(a) Identification. A lipase test system is a device intended to measure the activity of the enzyme lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct. (b) Classification. Class I .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K970805
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96