(31 days)
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No
The document describes a reagent for a chemistry analyzer and does not mention any AI or ML components.
No
The device is a reagent for the quantitative determination of C-reactive protein, which is used for diagnostic purposes, not for therapy or treatment.
Yes
The device is intended for the "quantitative determination of C-reactive protein concentration in serum or plasma," which is a diagnostic purpose to measure a specific biomarker in a biological sample.
No
The device is a reagent, which is a chemical substance used in a laboratory test, not a software-only medical device. The description explicitly refers to a "Reagent" and its use with a "Calibrator Set" and "SYNCHRON® Systems," indicating a hardware-dependent chemical assay.
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 C-reactive protein concentration in serum or plasma." Serum and plasma are biological samples taken in vitro (outside the body).
- Device Description: The description confirms it's a "reagent" used for "quantitative determination of human C-reactive protein by rate nephelometry." This is a laboratory technique performed on biological samples.
- Performance Studies: The performance studies describe method comparisons and imprecision studies, which are typical evaluations for IVD devices.
- Predicate Device: The predicate device listed is also an "Immunochemistry System C-Reactive Protein (CRP) Reagent," further indicating that this device falls within the category of IVDs.
The core function of the device is to analyze a biological sample (serum or plasma) in vitro to provide diagnostic information (CRP concentration). This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent , in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.
Product codes (comma separated list FDA assigned to the subject device)
DCK
Device Description
The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human C-reactive protein by rate nephelometry.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
Method Comparison for CRP Reagent
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Serum vs Plasma Study Summary
Deming Regression Analysis (mg/dL) for Lithium Heparin (14 Units/mL) was Y = 1.042X - 0.45; r = 0.977.
Deming Regression Analysis (mg/dL) for Sodium Heparin (14 Units/mL) was Y = 0.994X - 0.07; r = 0.989.
Deming Regression Analysis (mg/dL) for EDTA (1.5 mg/mL) was Y = 0.992X - 0.20; r = 0.967.
Estimated SYNCHRON CRP Reagent Imprecision
Within-Run Imprecision:
Level 1: Mean (IU/mL) = 1.03, S.D. (IU/mL) = 0.05, %C.V. = 4.46, N = 80
Level 2: Mean (IU/mL) = 4.06, S.D. (IU/mL) = 0.06, %C.V. = 1.58, N = 80
Level 3: Mean (IU/mL) = 7.09, S.D. (IU/mL) = 0.08, %C.V. = 1.14, N = 80
Total Imprecision:
Level 1: Mean (IU/mL) = 1.03, S.D. (IU/mL) = 0.06, %C.V. = 5.49, N = 80
Level 2: Mean (IU/mL) = 4.06, S.D. (IU/mL) = 0.18, %C.V. = 4.49, N = 80
Level 3: Mean (IU/mL) = 7.09, S.D. (IU/mL) = 0.25, %C.V. = 3.56, N = 80
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
§ 866.5270 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
BECKMAN
NOV 2 4 1997
Summary of Safety & Effectiveness SYNCHRON® Systems C-Reactive Protein (CRP) Reagent
1.0 Submitted By:
Annette Hellie Sr. Regulatory Specialist, Product Submissions Beckman Instruments, Inc. 200 S. Kraemer Blvd., W-337 Brea, California 92822-8000 Telephone: (714) 993-8767 FAX: (714) 961-4457
2.0 Date Submitted:
October 23, 1997
3.0 Device Name(s):
3.1 Proprietary Names
SYNCHRON® Systems C-Reactive Protein (CRP) Reagent
3.2 Classification Names
C-Reactive Protein immunological test system (21 CFR § 866.5270)
4.0 Predicate Device(s):
IMMAGE™ Immunochemistry System C-Reactive Protein (CRP) Reagent K963061
5.0 Description:
ﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ
The SYNCHRON Systems C-Reactive Protein (CRP) Reagent is designed for optimal performance on Beckman's SYNCHRON® Systems. It is intended for use in the quantitative determination of human C-reactive protein by rate nephelometry.
6.0 Intended Use:
The SYNCHRON® Systems C-Reactive Protein (CRP) Reagent , in conjunction with the SYNCHRON CX® CRP Calibrator Set, is intended for the quantitative determination of C-reactive protein concentration in serum or plasma.
1
Comparison to Predicate(s): 7.0
The following table shows similarities and differences between the predicates identified in Section 4.0 of this summary.
| Reagent | Aspect/Characteristic | Comments |
|---|---|---|
| SIMILARITIES | ||
| SYNCHRON | ||
| Systems CRP | ||
| Reagent | Sample types | |
| (serum/plasma) | Same as IMMAGE System CRP Reagent | |
| SYNCHRON | ||
| Systems CRP | ||
| Reagent | Shelf-life of 24 months | |
| (stored at 2-8°C) | Same as IMMAGE System CRP Reagent | |
| SYNCHRON | ||
| Systems CRP | ||
| Reagent | Antibody | Same as IMMAGE System CRP Reagent |
| DIFFERENCES | ||
| SYNCHRON | ||
| Systems CRP | ||
| Reagent | Calibrator | The SYNCHRON uses a five level system |
| calibration while the IMMAGE uses a single | ||
| cal point update. | ||
| SYNCHRON | ||
| Systems CRP | ||
| Reagent | Methodology | The SYNCHRON Systems CRP utilizes a |
| turbidimetric method while the IMMAGE | ||
| System CRP utilizes a nephelometric | ||
| method. |
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.
Method Comparison for CRP Reagent
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Serum vs Plasma Study Summary
| Anticoagulant | Level of Anticoagulant Tested | Deming Regression Analysis (mg/dL) |
|---|---|---|
| Lithium Heparin | 14 Units/mL | $Y = 1.042X - 0.45; r = 0.977$ |
| Sodium Heparin | 14 Units/mL | $Y = 0.994X - 0.07; r = 0.989$ |
| EDTA | 1.5 mg/mL | $Y = 0.992X - 0.20; r = 0.967$ |
Estimated SYNCHRON CRP Reagent Imprecision
| Sample | Mean (IU/mL) | S.D. (IU/mL) | %C.V. | N |
|---|---|---|---|---|
| Within-Run Imprecision | ||||
| Level 1 | 1.03 | 0.05 | 4.46 | 80 |
| Level 2 | 4.06 | 0.06 | 1.58 | 80 |
| Level 3 | 7.09 | 0.08 | 1.14 | 80 |
| Total Imprecision | ||||
| Level 1 | 1.03 | 0.06 | 5.49 | 80 |
| Level 2 | 4.06 | 0.18 | 4.49 | 80 |
| Level 3 | 7.09 | 0.25 | 3.56 | 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Annette Hellie Senior Regulatory Specialist, Product Submissions NOV 2 4 1997 Beckman Instruments, Inc. 200 S. Kraemer Boulevard, W-337 Brea, California 92822-8000
Re: K974050 SYNCHRON® System C-Reactive Protein (CRP) Reagent Trade Name: Requlatorv Class: II Product Code: DCK Dated: October 23, 1997 Received: October 24, 1997
Dear Ms. Hellie:
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, Drug, and Cosmetic Act (Act). 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 (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. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 Regulations.
3
Page 2
Under the Clinical Laboratory Improvement Amendments of 1988 (CDIA-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 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" (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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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): K974050
Device Name: SYNCHRON® Systems C-Reactive Protein (CRP) Reagent
Indications for Use:
The SYNCHRON® Systems C-Reactive Protein (CRP) Roagent, In conjunction with the SYNCHRON CX® CRP Calibrator Set. Is intended for the quantitative determination of C-reactive protein concentration in serum or plaema.
21 CFR 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. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. . . . - - --- ---- -----------------------------------------------------------------------------------------------------------------------------------. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
(b) Classification. Class II (performance standards)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE. IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off
beratory Devices 5100c) Nowel
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use Optional Format 1-2-96