(83 days)
N High Sensitivity CRP K991385
No
The description details a standard immunoturbidimetric assay and does not mention any AI or ML components.
No.
This device is an in vitro diagnostic immunoassay that quantifies C Reactive Protein in human plasma; it is used to aid in detecting and evaluating various conditions but does not directly treat or prevent them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases," which is a diagnostic purpose.
No
The device is an in vitro diagnostic immunoassay kit, which includes reagents and is used on specific laboratory instruments (IL Coagulation Systems). This involves physical components and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections:
- "HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay..."
- "HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays." (Controls for an IVD are also considered part of the IVD system).
N/A
Intended Use / Indications for Use
HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
Product codes
DCK, 81DCK
Device Description
Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
The HS-CRP is a latex particle enhanced immunoturbidimetric assay to quantify CRP in When a plasma containing CRP is mixed with the Latex Reagent and the Reaction plasma. Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. The test range is well suited to cover apparent normality as well as the requirements as a marker of infectious and inflammatory diseases.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human citrated plasma
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
Method Comparison: In method comparison studies evaluating 153 samples with CRP levels ranging from 0.18 to 258 mg/L on an ACL 9000 and an ACL Futura, the slopes and correlation coefficients (r) for HemosIL High Sensitivity -- C Reactive Protein versus the predicate device are shown below:
ACL 9000: Slope 0.972, Intercept -0.070, r 0.9950
ACL Futura: Slope 0.942, Intercept -0.027, r 0.9945
Precision: Within run and total precision assessed over multiple runs using two levels of control gave the following results:
ACL 9000: Low HS-CRP Control (Mean mg/L CRP 2.594, Within run CV% 1.75, Total CV% 2.57); High HS-CRP Control (Mean mg/L CRP 6.186, Within run CV% 1.01, Total CV% 1.50)
ACL Futura: Low HS-CRP Control (Mean mg/dL CRP 0.255, Within run CV% 3.04, Total CV% 3.42); High HS-CRP Control (Mean mg/dL CRP 0.607, Within run CV% 3.42, Total CV% 3.63)
Key Metrics
Not Found
Predicate Device(s)
N High Sensitivity CRP K991385
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
10232469
DEC 2 3 2002
Section 3 HemosIL High Sensitivity - C Reactive Protein 510(k) Summary (Summary of Safety and Effectiveness)
Submitted by:
Instrumentation Laboratory Company 113 Hartwell Avenue Lexington, MA 02421 Phone: 781-861-4467 Fax: 781-861-4207
Contact Person:
Carol Marble. Regulatory Affairs Manager Phone: 781-861-4467 / Fax: 781-861-4207
Summary Prepared:
September 30, 2002
Name of the Device:
HemosIL High Sensitivity - C Reactive Protein, AND HemosIL High Sensitivity - C Reactive Protein Controls
Classification Name(s):
| 866.5270 | C-Reactive Protein Immunological Test System | Class II |
|---|---|---|
| 81DCK | C-Reactive Protein, Antigen, Antiserum, and Control |
Identification of predicate device(s):
N High Sensitivity CRP K991385
Description of the device/intended use(s):
Hemos IL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases.
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
The HS-CRP is a latex particle enhanced immunoturbidimetric assay to quantify CRP in When a plasma containing CRP is mixed with the Latex Reagent and the Reaction plasma. Buffer included in the kit, the coated latex particles agglutinate. The degree of agglutination is directly proportional to the concentration of CRP in the sample and is determined by measuring the decrease of transmitted light caused by the aggregates. The test range is well suited to cover apparent normality as well as the requirements as a marker of infectious and inflammatory diseases.
Statement of Technological Characteristics of the Device Compared to Predicate Device:
HemosIL High Sensitivity - C Reactive Protein is substantially equivalent to the commercially available predicate device (N High Sensitivity CRP) in performance and intended use.
1
Section 3 HemosIL High Sensitivity - C Reactive Protein 510(k) Summary (Summary of Safety and Effectiveness)
Summary of Performance Data:
Method Comparison
In method comparison studies evaluating 153 samples with CRP levels ranging from 0.18 to 258 mg/L on an ACL 9000 and an ACL Futura, the slopes and correlation coefficients (r) for HemosIL High Sensitivity -- C Reactive Protein versus the predicate device are shown below:
| IL System | Slope | Intercept | r |
|---|---|---|---|
| ACL 9000 | 0.972 | -0.070 | 0.9950 |
| ACL Futura | 0.942 | -0.027 | 0.9945 |
Precision
Within run and total precision assessed over multiple runs using two levels of control gave the following results:
| ACL 9000 | Mean
mg/L CRP | Within run
CV% | Total
CV% |
|---------------------|-------------------|-------------------|--------------|
| Low HS-CRP Control | 2.594 | 1.75 | 2.57 |
| High HS-CRP Control | 6.186 | 1.01 | 1.50 |
| ACL Futura | Mean
mg/dL CRP | Within run
CV% | Total
CV% |
| Low HS-CRP Control | 0.255 | 3.04 | 3.42 |
| High HS-CRP Control | 0.607 | 3.42 | 3.63 |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three wavy lines that converge at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850
Ms. Carol Marble Regulatory Affairs Director Instrumentation Laboratory Company 101 Hartwell Avenue Lexington, MA 02421-3125
Re: K023269
Trade/Device Name: HemosIL High Sensitivity - C Reactive Protein AND HemosIL High Sensitivity - C Reactive Protein Controls Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: December 16, 2002 Received: December 17, 2002
Dear Ms. Marble:
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. Drue, 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).
3
Page 2 -
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.
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: HemosIL High Sensitivity - C Reactive Protein AND HemosIL High Sensitivity - C Reactive Protein Controls
Indications for Use:
HemosIL High Sensitivity - C Reactive Protein is an in vitro diagnostic high sensitivity automated latex enhanced immunoassay for the quantitative determination of C Reactive Protein in human citrated plasma on IL Coagulation Systems. C Reactive Protein (CRP) aids in detecting and evaluating infection, tissue disorder, inflammatory disorders and associated diseases,
HemosIL High Sensitivity - C Reactive Protein Controls are assayed human serum controls intended to monitor the accuracy and precision of quantitative C Reactive Protein (CRP) assays.
Jean Coogh
(Division Sign-Off)
Division or Clinical Laboratory Devices
510(k) Number 6023269
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.019) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
High Sensitivity - C Reactive Protein 510(k)