(66 days)
No
The summary describes a reagent and calibrator for a chemistry analyzer, using rate turbidimetry. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is a reagent used for diagnostic testing (quantitative determination of human C-reactive protein), not for therapy.
Yes
This device is a reagent and calibrator used for the "quantitative determination of human C-reactive protein in human serum and plasma samples," which is a diagnostic measurement used to assess inflammation in the body.
No
The device description clearly states it is a reagent kit, which is a chemical substance used in a chemical reaction, not a software program.
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 human C-reactive protein in human serum and plasma samples." This is a classic description of an in vitro diagnostic test, as it involves analyzing biological samples outside of the body to provide information about a patient's health status.
- Device Description: The device is a "reagent" designed for use on specific laboratory "Systems" (SYNCHRON CX and LX). Reagents used for analyzing biological samples in a laboratory setting are a core component of IVDs.
- Performance Studies: The document describes performance studies like "method comparison, linearity, and imprecision experiments," which are standard evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device(s): The mention of "Predicate Device(s)" with K numbers (K010597 and K910535) indicates that this device is being compared to previously cleared IVD devices, a common process for demonstrating substantial equivalence for new IVDs.
All these factors strongly indicate that this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX Systems and CX C-RP Calibrator on SYNCHRON CX Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples on SYNCHRON Systems by rate turbidimetry. CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-RP Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.
Product codes
DCN, JIS
Device Description
The SYNCHRON Systems C-RP reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/54/5PRO, CX7/7RTS/7/2/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.
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
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, linearity, and imprecision experiments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
C-RP: 0.20 mg/dL (CX), 0.10 mg/dL (LX)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
16021572
JUL 1 9 2002
510(k) Summary SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator
1.0 Submitted By:
Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-104 Brea, California 92822-8000 Telephone: (714) 961-3777 FAX: (714) 961-4123
2.0 Date Submitted:
May 13, 2002
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent SYNCHRON Systems CX® C-RP Calibrator
3.2 Classification Name
C-Reactive Protein immunological test system (21 CFR § 866.5270) Primary Calibrator (21 CFR § 862.1150)
4.0 Predicate Device:
| Candidate(s) | Predicate | Manufacturer | Docket
Number |
|-----------------------------------------|--------------------------------------|---------------------------|------------------|
| SYNCHRON® Systems
C-RP Reagent | SYNCHRON LX®
Systems CRPH Reagent | Beckman Coulter,
Inc.* | K010597 |
| SYNCHRON Systems
CX® C-RP Calibrator | SYNCHRON Systems
CRP Calibrator | Beckman Coulter, Inc. | K910535 |
*Beckman Coulter, Inc., Brea, CA
5.0 Description:
The SYNCHRON Systems C-RP reagent is designed for optimal performance on the SYNCHRON CX (CX4/4CE/4/4PRO, CX5/5CE/54/5PRO, CX7/7RTS/7/2/7PRO, CX9ALX/9PRO) and LX (LX20/PRO) Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrators.
6.0 Intended Use:
C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX Systems and CX C-RP Calibrator on SYNCHRON CX Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples on SYNCHRON Systems by rate turbidimetry. CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-RP Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.
1
7.0 Comparison to Predicate(s):
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Similarities | ||
|---|---|---|
| C-RP Reagent | Intended Use | Same as Beckman Coulter |
| SYNCHRON LX Systems High | ||
| Sensitivity CRPH Reagent | ||
| Use of Latex particle technology | ||
| Sample Type | ||
| Antibody source (mouse, goat) | ||
| Liquid-stable reagents | ||
| Differences | ||
| Detection Wavelength | C-RP: 600 nm | |
| CRPH: 910 nm | ||
| Platform | C-RP: All CX and LX models | |
| CRPH: LX PRO models only | ||
| Initial Measuring Range | C-RP: 0.20 to 25 mg/dL (CX) | |
| 0.10 to 25 mg/dL (LX) | ||
| CRPH: 0.02 to 8 mg/dL | ||
| Extended Measuring Range | C-RP: up to 50 mg/dL | |
| CRPH: up to 38 mg/dL | ||
| Sensitivity | C-RP: 0.20 mg/dL (CX), | |
| 0.10 mg/dL (LX) | ||
| CRPH: 0.02 mg/dL |
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, linearity, and imprecision experiments.
| SYNCHRON Systems C-RP Method Comparison Study Results | ||
|---|---|---|
| Candidate Method | Platform | Slope | Intercept | R | n | Predicate Method |
|---|---|---|---|---|---|---|
| SYNCHRON | ||||||
| Systems C-RP | CX | 1.007 | 0.05 | 0.996 | 132 | Beckman Coulter |
| Reagent | LX | 1.033 | 0.01 | 0.998 | 143 | SYNCHRON LX Systems |
| CRPH Assay |
| Sample | Mean (mg/dL) | S.D. (mg/dL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 0.49 | 0.014 | 2.77 | 80 |
| Level 2 | 5.40 | 0.063 | 1.17 | 80 |
| Level 3 | 13.45 | 0.210 | 1.56 | 80 |
| Level 4 | 23.99 | 0.598 | 2.49 | 80 |
| Total Imprecision | ||||
| Level 1 | 0.49 | 0.017 | 3.45 | 80 |
| Level 2 | 5.40 | 0.086 | 1.60 | 80 |
| Level 3 | 13.45 | 0.287 | 2.13 | 80 |
| Level 4 | 23.99 | 0.624 | 2.60 | 80 |
SYNCHRON LX System C-RP Estimated Imprecision
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.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and the background is white. There is a logo to the left of the text.
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the top and left side. Inside the circle is a stylized image of an eagle with three lines forming the body and head, and two curved lines forming the legs and feet.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Mary Beth Tang Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Boulevard, W-104 P.O. Box 8000 Brea, California 92822-8000
JUL 1 9 2002
K021572 Re:
Trade/Device Name: SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator Regulation Number: 21 CFR § 866.5270 and 21 CFR § 862.1150 Regulation Name: C-Reactive Protein Immunological Test System and Primary Calibrator Regulatory Class: II Product Code: DCN, JIS Dated: May 13, 2002 Received: May 14, 2002
Dear Ms. Tang:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set
3
Page 2
This letter will allow you to begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic 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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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
510(k) Number (if known):
Device Name:
SYNCHRON® Systems C-Reactive Protein (C-RP) Reagent and Calibrator
Indications for Use:
C-RP reagent, when used in conjunction with SYNCHRON CAL 5 Plus on SYNCHRON LX® Systems and CX® C-RP Calibrator on SYNCHRON CX® Systems, is intended for use in the quantitative determination of human C-reactive protein in human serum and plasma samples by rate turbidimetry. Measurement of C-reactive protein aids in evaluation of stress, trauma, infection, inflammation, and surgery.
KO21572
CX C-RP Calibrator, when used in conjunction with SYNCHRON Systems C-Reactive Protein (C-RP) Reagent, is intended for the calibration of C-reactive protein test systems on SYNCHRON CX Systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1/Reeve for E. Altaie
(Division Sign-Off) Division of Clinical Laboratory Device 510(k) Number _
Prescription Use
(per 21 CFR 801.109)
OR
. '
Over-the-Counter Use Optional Format 1-2-96