(108 days)
Not Found
No
The summary describes electrophoresis kits and their performance characteristics, with no mention of AI or ML.
No.
This device is designed for the electrophoretic separation and identification of proteins in human urine for diagnostic purposes, not for treatment.
Yes
The device is intended for the electrophoretic separation of proteins and the immunologic identification of monoclonal components in human urine, which are tests performed to aid in disease diagnosis. The performance studies also compare this device to existing chemistry test systems.
No
The device description explicitly details physical components like "Segment packages," "Desalting Column packages," and "Desalting Reagent bottles," indicating it is a kit containing hardware/reagents, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the kits are for the "electrophoretic separation of proteins in human urine" and the "immunologic identification of monoclonal components in human urine." These are diagnostic procedures performed on a biological sample (urine) outside of the body.
- Device Description: The description details kits containing reagents and components used in a laboratory setting for performing these tests.
- Anatomical Site: The sample being analyzed is "human urine," a biological specimen.
- Performance Studies: The document includes performance studies demonstrating the device's analytical performance (method comparison, imprecision, reproducibility) for diagnostic purposes.
- Predicate Devices: The predicate devices listed (PARAGON SPE Kit and PARAGON IFE Kit) are also IVD devices used for similar diagnostic purposes.
All of these factors 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 diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the electrophoretic separation of proteins in human urine.
The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the immunologic identification of monoclonal components in human urine.
Product codes (comma separated list FDA assigned to the subject device)
JKM, CFF, DFH, DEH
Device Description
The PARAGON CZE® 2000 UPE and U-IFE/s kits are designed for optimal performance on the PARAGON CZE® 2000. The UPE kits contain one Segment package containing 20 Segments, five Desalting Column packages with 4 columns per package, and four 500 mL Desalting Reagent bottles. The U-IFE/s kits contain two Segment packages containing 10 Segments, one Desalting Column package with 4 columns per package, and one 500 mL Desalting Reagent bottle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
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 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/sensitivity, and precision/ reproducibility experiments.
Method Comparison Study Results:
PARAGON CZE 2000 – UPE Kit: Agreement 95%, Partial Agreement 4%, Disagreement 1%, n=100. Comparison Method: PARAGON Gel Electrophoresis – SPE Kit.
PARAGON CZE 2000 – U-IFE/s Kit: Full Agreement 76 (92.7%), Disagreement 6 (7.3%), n=82. Comparison Method: PARAGON Gel Electrophoresis – IFE Kit.
Imprecision Results (UPE):
Within-Run Imprecision: System Reproducibility (Urine Pool): Albumin Mean 55.1%, S.D. 1.38%, %C.V. 2.5%, N=21; BJP Mean 13.2%, S.D. 0.93%, %C.V. 7.1%, N=21.
Desalting Reproducibility (Urine Pool): Albumin Mean 54.8%, S.D. 1.65%, %C.V. 3.0%, N=21; BJP Mean 13.5%, S.D. 0.71%, %C.V. 5.3%, N=21.
Total Imprecision (EP 10-A):
Urine Level 1: Albumin Mean 28.8%, S.D. 0.7%, %C.V. 2.5%, N=15; BJP Mean 13.4%, S.D. 0.8%, %C.V. 5.9%, N=15.
Urine Level 2: Albumin Mean 60.8%, S.D. 1.3%, %C.V. 2.2%, N=15; BJP Mean 6.5%, S.D. 0.8%, %C.V. 12.7%, N=15.
Urine Level 3: Albumin Mean 9.2%, S.D. 0.8%, %C.V. 9.2%, N=15; BJP Mean 72.1%, S.D. 1.5%, %C.V. 2.0%, N=15.
U-IFE/s Reproducibility Results:
The electropherograms were visually inspected to ensure that at least 80% were within agreement. No observable difference in morphology or subtraction was seen between the segments for each of the samples tested. BJP subtraction with kappa and lambda was as expected. Reproducibility meets the 80% specification for visual agreement for the replicate segments.
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
§ 866.5150 Bence-Jones proteins immunological test system.
(a)
Identification. A Bence-Jones proteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the Bence-Jones proteins in urine and plasma. Immunoglobulin molecules normally consist of pairs of polypeptide chains (subunits) of unequal size (light chains and heavy chains) bound together by several disulfide bridges. In some cancerous conditions, there is a proliferation of one plasma cell (antibody-producing cell) with excess production of light chains of one specific kind (monoclonal light chains). These free homogeneous light chains not associated with an immunoglobulin molecule can be found in urine and plasma, and have been called Bence-Jones proteins. Measurement of Bence-Jones proteins and determination that they are monoclonal aid in the diagnosis of multiple myeloma (malignant proliferation of plasma cells), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins by spleen and bone marrow cells), leukemia (cancer of the blood-forming organs), and lymphoma (cancer of the lymphoid tissue).(b)
Classification. Class II (performance standards).
0
Ko50119
MAY - 6 21:5
510(k) Summary Beckman Coulter PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit and Urine Immunofixation By Subtraction (U-IFE/s) Kit
Submitted By: 1.0
Kim Walker Requlatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-515 Brea, California 92822-8000 Telephone: (714) 961-4912 FAX: (714) 961-3969
2.0 Date Submitted:
January 14, 2005
3.0 Device Name(s):
.
Proprietary Names 3.1
PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit
PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit
3.2 Classification Name
UPE & U-IFE/s - Bence-Jones proteins immunological test (21 CFR $ 866.5150)
1
Predicate Devices: 4.0
| Candidate | Predicate | Manufacturer | Docket
Number |
|---------------------------------|-----------------|--------------------------|------------------|
| PARAGON CZE
2000 UPE Kit | PARAGON SPE Kit | Beckman
Coulter, Inc. | K802592 |
| PARAGON CZE
2000 U-IFE/s Kit | PARAGON IFE Kit | Beckman
Coulter, Inc. | K823884 |
5.0 Description:
The PARAGON CZE® 2000 UPE and U-IFE/s kits are designed for optimal performance on the PARAGON CZE® 2000. The UPE kits contain one Segment package containing 20 Segments, five Desalting Column packages with 4 columns per package, and four 500 mL Desalting Reagent bottles. The U-IFE/s kits contain two Segment packages containing 10 Segments, one Desalting Column package with 4 columns per package, and one 500 mL Desalting Reagent bottle.
6.0 Intended Use:
The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the electrophoretic separation of proteins in human urine.
The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the immunologic identification of monoclonal components in human urine.
2
Comparison to Predicate(s): 7.0
The following tables show similarities and differences between the predicate identified in Section 4.0 of this summary.
| Kit | Aspect/Characteristic | Comments |
|---|---|---|
| UPE Kit | Basic Technology (Electrophoretic Migration) | Same as Beckman |
| Paragon SPE Kit | ||
| Urine Sample Type | ||
| Shelf Life Stability | ||
| Specificity | ||
| Qualitative Results | ||
| U-IFE/s Kit | Basic Technology (Electrophoretic Migration | |
| with Immunofixation) | Same as Beckman | |
| Paragon IFE Kit | ||
| Urine Sample Type | ||
| Qualitative Results | ||
| Shelf Life Stability | ||
| Antisera Storage | ||
| Antisera Specificity |
Similarities to the Predicate
3
Differences From The Predicate
| Kit | Aspect/
Characteristic | Comments |
|----------------|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| UPE Kit | Intended Use | The Paragon CZE 2000 Urine Protein Electrophoresis
(UPE) Kit is intended for use with the Paragon CZE
2000 Capillary Electrophoresis System for the
electrophoretic separation of proteins in human urine.
The Paragon Serum Protein Electrophoresis (SPE) Kit
is intended for the electrophoretic separation of
proteins in human serum, cerebrospinal fluid, and urine. |
| | Sample Preparation | UPE - No concentration required for urine samples
with a total protein of 20-4800 mg/dL. Must desalt
before running sample on CZE. Any samples 4800 mg/dL must
be diluted.
SPE - Concentration required for all urine samples
700 mg/dL |
| Kit | Aspect/
Characteristic | Comments |
| U-IFE/s
Kit | Intended Use | The Paragon CZE 2000 Urine Immunofixation by
Subtraction (U-IFE/s) Electrophoresis Kit is intended
for use with the Paragon CZE 2000 Capillary
Electrophoresis System for the immunologic
identification of monoclonal components in human
urine.
The Paragon Immunofixation Electrophoresis (IFE) Kit
is for the immunologic identification of proteins in
human serum, cerebrospinal fluid, and urine. |
| | Sample Preparation | U-IFE/s - No concentration required for urine samples
w/ monoclonal components of 5 - 300 mg/dL. Must
desalt before running sample on CZE. Any samples
300 mg/dL of monoclonal
components must be diluted.
IFE - Concentration required for all urine samples
100 mg/dL for detection of Bence-
Jones Proteins. Total Protein >800-1000 mg/dL for
detection of immunoglobulins. |
4
.
5
Summary of Performance Data: 8.0
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/sensitivity, and precision/ reproducibility experiments.
| Instrument | Agreement | Partial
Agreement | Disagreement | n | Comparison
Method |
|----------------------------------|-----------|----------------------|--------------|-----|---------------------------------------------|
| PARAGON
CZE 2000
– UPE Kit | 95 | 4 | 1 | 100 | PARAGON Gel
Electrophoresis –
SPE Kit |
Method Comparison Study Results
| Instrument | Full Agreement | Disagreement | n | Comparison Method |
|---|---|---|---|---|
| PARAGON | ||||
| CZE 2000 | ||||
| – U-IFE/s | ||||
| Kit | 76 | |||
| (92.7%) | 6 | |||
| (7.3%) | 82 | PARAGON Gel | ||
| Electrophoresis – IFE | ||||
| Kit |
6
| Type of
Imprecision | Sample | Fraction | Mean
(Relative %) | S.D.
(Relative %) | %
C.V. | N |
|------------------------------|------------------|----------|----------------------|----------------------|-----------|----|
| Within-Run Imprecision | | | | | | |
| System
Reproducibility | Urine
Pool | Albumin | 55.1 | 1.38 | 2.5 | 21 |
| | | BJP | 13.2 | 0.93 | 7.1 | 21 |
| Desalting
Reproducibility | Urine
Pool | Albumin | 54.8 | 1.65 | 3.0 | 21 |
| | | BJP | 13.5 | 0.71 | 5.3 | 21 |
| Total Imprecision | | | | | | |
| Total
(EP 10-A) | Urine
Level 1 | Albumin | 28.8 | 0.7 | 2.5 | 15 |
| | | BJP | 13.4 | 0.8 | 5.9 | 15 |
| | Urine
Level 2 | Albumin | 60.8 | 1.3 | 2.2 | 15 |
| | | BJP | 6.5 | 0.8 | 12.7 | 15 |
| | Urine
Level 3 | Albumin | 9.2 | 0.8 | 9.2 | 15 |
| | | BJP | 72.1 | 1.5 | 2.0 | 15 |
UPE Imprecision Results
U-IFE/s Reproducibility Results
The electropherograms were visually inspected to ensure that at least 80% were within agreement. No observable difference in morphology or subtraction was seen between the segments for each of the samples BJP subtraction with kappa and lambda was as expected. tested. Reproducibility meets the 80% specification for visual agreement for the replicate segments.
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.
7
Image /page/7/Figure/0 description: The image is a flowchart outlining the process for determining substantial equivalence under Section 510(k) of the FDA regulations. The flowchart starts with the question of whether the new device is compared to a marketed device. The flowchart then proceeds through a series of questions about the device's indications, intended use, technological characteristics, and the availability of performance data. The flowchart ends with a determination of whether the device is substantially equivalent or not.
CZE_UPE & UIFES 510K_Section1, January 2005
8
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
MAY - 6 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Walker, RAC Regulatory Affairs Manager Beckman Coulter, Inc. 200 S. Kraemer Boulevard M/S W-515 Brea, California 92822-8000
Re: K050119
Trade/Device Name: PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit and Urine Immunofixation by Subtraction (U-IFE/s) Kit Regulation Number: 21 CFR § 866.5150 Regulation Name: Bence-Jones proteins immunological test Regulatory Class: II Product Code: JKM, CFF, DFH, DEH Dated: March 30, 2005 Received: March 31, 2005
Dear Ms Walker:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
9
Page 2 –
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PK.D Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
10
Indications for Use
Koro 119
510(k) Number (if known):
Device Name:
PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit and Urine Immunofixation By Subtraction (U-IFE/s) Kit
Indications for Use:
The PARAGON CZE® 2000 Urine Protein Electrophoresis (UPE) Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the electrophoretic separation of proteins in human urine.
The PARAGON CZE® 2000 Urine Immunofixation by Subtraction (U-IFE/s) Electrophoresis Kit is intended for use with the Paragon CZE 2000 Capillary Electrophoresis System for the immunologic identification of monoclonal components in human urine.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Sunshine Burutta
Division Sign
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050119
Beckman Coulter, Inc., Section 510(k) Notification PARAGON CZE® 2000 UPE & U-IFE/s Kits CZE_UPE & UIFEs 510K_Section1 Final.doc, January 2005 Page 1 of ____________________________________________________________________________________________________________________________________________________________________