(106 days)
Not Found
No
The device description details a system based on immunoassay, solid-phase technology, reflectance photometry, and magnetic stripe calibration. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic test for the quantitative determination of CRP and is intended as an aid in detection and evaluation of conditions, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic test for the quantitative determination of CRP" and is "useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a system that includes hardware components (Analyzer, cassettes, capillary tubes) and relies on physical processes (immunoassay, solid-phase technology, reflectance photometry) to measure CRP. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum.
Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Product codes (comma separated list FDA assigned to the subject device)
DCK
Device Description
The Cholestech LDX System combines immunoassay and solid-phase technology to measure CRP. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX hs-CRP cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The resultant color in the reaction is measured by reflectance photometry.
A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading to the CRP concentration in mg/L.
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
Professional-Use, point-of-care
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)
- Assay range: 0.2- 10 mg/L .
- Hematocrit tolerance: 30-55% .
- Interference testing: less than 10% interference when challenged by evaluated levels of . endogenous substances
- Precision: 2 levels of Controls (Low- ~1.2 mg/L CRP, and High- ~2.9 mg/L CRP) were . tested in duplicate, twice a day, over a 20 day period for a total of 80 replicates per level. The percent coefficient of variation (%CV) from the testing of the Low Control was 14.3%, and 11.5% from the testing of the High Control. When the same testing protocol was performed with a serum sample at 6.5 mg/L, the %CV was 11.4%.
- Accuracy: The LDX hs-CRP test was compared to the Dade Behring N high sensitivity CRP . test with 70 matched serum samples. Additionally, results obtained from testing 76 whole blood samples (both venous and fingerstick) on the LDX were compared to the serum results obtained on the Dade Behring N high sensitivity CRP. (Dade Behring N high sensitivity CRP on x-axis).
| n | slope | y-intercept | "r" | Range of Values | |
|---|---|---|---|---|---|
| Serum | 70 | 1.01 | 0.22 | 0.975 | 0.20 - 7.18 mg/L |
| Whole Blood | 76 | 1.06 | 0.07 | 0.976 | 0.20 - 7.18 mg/L |
| Fingersticks | 76 | 1.08 | -0.02 | 0.981 | 0.20 - 8.65 mg/L |
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
§ 866.5270 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
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: KLYCS 79
Submitter Information (21 CFR 807.92(a)(1))
Cholestech Corporation Submitter: 3347 Investment Boulevard Hayward, CA 94545 phone: (510) 732-7200 (510) 732-7227 fax:
- Thomas E. Worthy, PhD. Contact: Vice President, Research and Regulatory Affairs Cholestech Corporation.
March 1, 2004 Summary Date:
Name of Device and Classification (21 CFR 807.92(a)(2))
| Name (trade): | Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) |
|---|---|
| Name (usual): | Immunoassay for the determination of C-Reactive Protein (CRP) |
| Classification: | 21 CFR 866.5270, Class II, Product code DCK |
Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3))
LDX hs-CRP is substantially equivalent to the Dade Behring N High Sensitivity CRP assay on the BN100 (Dade Behring, Newark, DE). The LDX hs-CRP method is identical or similar to its predicate in terms of: intended use, measurement principle (immunoassay), undiluted sample measurement (assay) range, specimen type, and the requirement for an analyzer.
1
Description of Device (21 CFR 807.92 (a)(4))
The Cholestech LDX System combines immunoassay and solid-phase technology to measure CRP. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin coated capillary tube), venous whole blood or serum. The sample is applied to a Cholestech LDX hs-CRP cassette. The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells. The resultant color in the reaction is measured by reflectance photometry.
A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading to the CRP concentration in mg/L.
Intended Use (21 CFR 807.92 (a)(5))
Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of CRP in whole blood or serum.
Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))
A summary table of the similarities and differences between the LDX hs-CRP and the predicate device follows.
| Device Name | LDX hs-CRP
(new device) | Dade Behring N High Sensitivity CRP
Assay
(K991385) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for use | Cholestech LDX high sensitivity C-
Reactive Protein (hs-CRP) test is an
in vitro diagnostic test for the
quantitative determination of C-
reactive protein (CRP) in whole
blood or serum.
Measurement of CRP is useful as
an aid in the detection and
evaluation of infection, tissue | N High Sensitivity CRP is an in vitro
diagnostic assay intended for the quantitative
determination of C-reactive protein (CRP) in
human serum and heparin- and EDTA- plasma
by means of particle enhanced
immunonephelometry using BN™ Systems. In
acute phase response, increased levels of a
number of plasma proteins, including C-
reactive protein, are observed. Measurement |
Comparison Table: Cholestech LDX bs-CRP vs Dade Behring BN100 high sensitivity CRP
2
| Device Name | LDX hs-CRP
(new device) | Dade Behring N High Sensitivity CRP
Assay
(K991385) |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | injury, inflammatory disorders and
associated diseases. | of CRP is useful for the detection and
evaluation of infection, tissue injury,
inflammatory disorders and associated
diseases |
| Instrument
Required | Cholestech LDX Analyzer | Dade Behring BN-100 Nephelometer |
| Technology | Lateral flow immunoassay utilizing
colloidal gold particles coated with
monoclonal antibodies detected by
reflectance spectrophotometry. | Agglutination of polystyrene particle coated
with monoclonal antibodies detected by
nephelometry |
| Assay Range | 0.2 to 10 mg/L | 0.175 to 11 mg/L
up to 1100 mg/dL with sample dilution |
| Sample Type | Whole blood (capillary and venous)
and serum | Serum or plasma |
| Calibration
Requirements | No calibration performed by the
user; test information is encoded on
the magnetic stripe of the cassette,
and the stripe is read by the LDX
Analyzer each time a cassette is
run. | Calibration required via the use of the N CRP
Standard SY; under typical operating
conditions, the HS-CRP reagents must be
calibrated every 4 weeks, and also with certain
parts replacement or maintenance procedures. |
| Testing
Environment | Professional-Use, point-of-care | Professional-Use, conventional laboratory |
Brief Discussion of Nonclinical and Clinical Performance Data (21 CFR 807.92(b)(1,2,3)}
- Assay range: 0.2- 10 mg/L .
- Hematocrit tolerance: 30-55% .
- Interference testing: less than 10% interference when challenged by evaluated levels of . endogenous substances
- Precision: 2 levels of Controls (Low- ~1.2 mg/L CRP, and High- ~2.9 mg/L CRP) were . tested in duplicate, twice a day, over a 20 day period for a total of 80 replicates per level. The percent coefficient of variation (%CV) from the testing of the Low Control was 14.3%, and 11.5% from the testing of the High Control. When the same testing protocol was performed with a serum sample at 6.5 mg/L, the %CV was 11.4%.
3
- Accuracy: The LDX hs-CRP test was compared to the Dade Behring N high sensitivity CRP . test with 70 matched serum samples. Additionally, results obtained from testing 76 whole blood samples (both venous and fingerstick) on the LDX were compared to the serum results obtained on the Dade Behring N high sensitivity CRP. (Dade Behring N high sensitivity CRP on x-axis).
| n | slope | y-intercept | "r" | Range of Values | |
|---|---|---|---|---|---|
| Serum | 70 | 1.01 | 0.22 | 0.975 | 0.20 - 7.18 mg/L |
| Whole Blood | 76 | 1.06 | 0.07 | 0.976 | 0.20 - 7.18 mg/L |
| Fingersticks | 76 | 1.08 | -0.02 | 0.981 | 0.20 - 8.65 mg/L |
LDX hs-CRP vs Dade Behring N high sensitivity CRP
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
JUN 1 8 2004
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Thomas E. Worthy, Ph.D. Vice President, Development and Regulatory Affairs Cholestech Corp. 3347 Investment Blvd. Hayward, CA 94545
K040579 Re:
K040377
Trade/Device Name: Cholestech LDX High-Sensitivity C-Reactive Protein (HS-CRP) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCK Dated: May 19, 2004 Received: May 20, 2004
Dear Dr. Worthy:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to the enactment date of the Medical Device Amendments, or to conninered pror to rial) 2011-11-11, accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Cosmetic For (110) that the device, subject to the general controls provisions of the Act. The I ou may, merelore, mainer of the Act include requirements for annual registration, listing of general controls profisioning 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 your device is elassine additional controls. Existing major regulations affecting your device It may be subject to bach added 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 r lease be action and i bermination that your device complies with other requirements of the Act that I Dri has intatutes and regulations administered by other Federal agencies. You must or any it cacial statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Tits Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to ough manceing of substantial equivalence of your device to a legally premarket notification: "The PDF intentigation 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, If you desire specific mionitiation assessions of your device, please contact the Office of of questions on the promises and Safety at (301) 594-3084. Also, please note the In Vir o Diagliostic Do rios Branding by reference to premarket notification" (21CFR Part 807.97). Tegulation other general information on your responsibilities under the Act from the Tou may oounn outer gefarers, 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,
Jean M. Cooper, MS, Div.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K040579
Device Name: Cholestech LDX High-Sensitivity C-Reactive Protein (HS-CRP)
Indications For Use:
Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the Cholestech LDX high sensitive i tolen (no only in end in servin. Measurement of CRP is
quantitative determination C-reactive protein in whole blood or serving inflammatory quantitative determination citeactive protein in whole blood be of the counting to the matory
useful as an aid in the detection and evaluation of infection, tissue injury, in disorders, and associated diseases.
Prescription Use _ x x (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)
Carl C. Benson
Division Stop-Off
Office of In Vito Diognos Device Evaluation and Sc
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