(108 days)
Not Found
No
The device description and performance studies focus on a photometric immunoassay method, which is a standard laboratory technique and does not mention or imply the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No.
This device is an in vitro diagnostic reagent cartridge used to measure C-reactive protein, which aids in evaluating body tissue injury. It does not directly treat or prevent a disease or condition, but rather provides information for diagnostic purposes.
Yes
The device is intended for the quantitative determination of C-reactive protein, and "Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues," which is a diagnostic purpose. The description also explicitly states "For in vitro diagnostic use only."
No
The device description clearly states it is a "reagent cartridge" used with a "Clinical Analyzer," indicating it is a physical component (reagent) and relies on hardware (the analyzer) for its function. It is an in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Intended Use: The device is intended for the "quantitative determination of C-reactive protein concentration in serum or heparin plasma." This is a test performed on biological samples outside of the body to provide information about a patient's health status.
- Device Description: The description details a "quantitative in vitro diagnostic determination of CRP in serum or heparin plasma."
- Care Setting: It is intended for use in "clinical laboratories or physician office laboratories," which are typical settings for IVD testing.
N/A
Intended Use / Indications for Use
The S-Test C-Reactive Protein Reagent Cartridge is intended for the quantitative determination of C-reactive protein concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
The S-Test C-Reactive Protein (CRP) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CRP in serum or heparin plasma based on a photometric test measuring the agglutination that results when an antigen-antibody reaction occurs between CRP in the sample and anti-CRP mouse monoclonal antibody-coated latex.
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
clinical laboratories or physician office laboratories.
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)
Performance data on S-Test CRP reagent included precision, accuracy, and sensitivity data.
Precision: In testing at three CRP levels for 24 days, the within-run CV ranged from 1.1 to 3.0% and total CV ranged from 2.3 to 4.3%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 1.0 to 7.5% and total CV ranged from 1.5 to 7.5%.
Accuracy: In the correlation study, 95 samples with CRP values ranging from 5 to 91 mg/L were assayed on the S40 Clinical Analyzer using S-Test CRP (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.995, a standard error estimate of 2.1, a confidence interval slope of 0.961 to 1.004, and a confidence interval intercept of 0.4 to 1.6. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 0.997 to 0.998, standard error estimates of 1.5 to 1.6, confidence interval slopes of 0.934 to 0.986 and confidence interval intercepts of -0.1 to 2.1.
Sensitivity: The detection limit was 2 mg/L.
Serum vs. Plasma: A study was performed by running CRP determinations on 22 paired samples drawn from the same patients in serum and heparin plasma tubes. The use of plasma was confirmed in a matrix comparison study using the paired t-test for means: Range: 7 to 96 mg/L (serum), t-Statistic = 0.13, t-Critical value 2.08 at a = 0.05, not statistically significant.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision: within-run CV ranged from 1.1 to 3.0% and total CV ranged from 2.3 to 4.3%. within-run CV ranged from 1.0 to 7.5% and total CV ranged from 1.5 to 7.5%.
Accuracy: correlation coefficient of 0.995, standard error estimate of 2.1, confidence interval slope of 0.961 to 1.004, and confidence interval intercept of 0.4 to 1.6. correlation coefficients of 0.997 to 0.998, standard error estimates of 1.5 to 1.6, confidence interval slopes of 0.934 to 0.986 and confidence interval intercepts of -0.1 to 2.1.
Sensitivity: detection limit was 2 mg/L.
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).
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JAN 3 0 2009
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC
4 Henderson Drive
West Caldwell, NJ 07006 |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dennis Taschek
Phone: 973-852-0177
Fax: 973-852-0237 |
| Date Summary
Prepared: | October 13, 2008 |
| Device: | Trade Name:
S-Test CRP Reagent cartridge |
| | Classification:
Class II |
| | Common/Classification
Name:
CRP: C-reactive protein test system
(21 C.F.R. § 866.5270), Product code DCN |
| Predicate
Device: | Manufacturers for analyzer/reagent system predicate is:
Olympus AU640 Clinical Chemistry Analyzer
CRP Latex Reagent (K961274) |
| Device
Description: | The S-Test C-Reactive Protein (CRP) reagent cartridge, used with the S40
Clinical Analyzer, is intended for quantitative in vitro diagnostic determination
of CRP in serum or heparin plasma based on a photometric test measuring the
agglutination that results when an antigen-antibody reaction occurs between
CRP in the sample and anti-CRP mouse monoclonal antibody-coated latex. |
| Intended Use: | The S-Test C-Reactive Protein Reagent Cartridge is intended for the
quantitative determination of C-reactive protein concentration in serum or
heparin plasma using the S40 Clinical Analyzer. Measurement of C-reactive
protein aids in evaluation of the amount of injury to body tissues. This test is
intended for use in clinical laboratories or physician office laboratories. For in
vitro diagnostic use only. |
| Technological
Characteristics: | The S-Test CRP Reagent is contained in a bi-reagent cartridge. Reagent 1
contains: 2-amino-2-hydroxymethyl-1,3-propanediol buffer (pH 8.5, 20
mmol/L). Reagent 2 contains: anti-human C-reactive mouse protein and
monoclonal antibody-coated latex (2 mg/mL). |
| Performance
Data: | Performance data on S-Test CRP reagent included precision, accuracy, and
sensitivity data. |
| | Precision: In testing at three CRP levels for 24 days, the within-run CV ranged
from 1.1 to 3.0% and total CV ranged from 2.3 to 4.3%. In precision studies at
three separate Physician Office Laboratory (POL) sites and in-house over five
days, the within-run CV ranged from 1.0 to 7.5% and total CV ranged from 1.5
to 7.5%. |
| | Accuracy: In the correlation study, 95 samples with CRP values ranging from
5 to 91 mg/L were assayed on the S40 Clinical Analyzer using S-Test CRP (y)
and a comparative method (x). Least-squares regression analysis yielded a
correlation coefficient of 0.995, a standard error estimate of 2.1, a confidence
interval slope of 0.961 to 1.004, and a confidence interval intercept of 0.4 to
1.6. In patient correlation studies at three separate POL sites using the S40
Clinical Analyzer and a comparative method, least-squares regression analysis
yielded correlation coefficients of 0.997 to 0.998, standard error estimates of
1.5 to 1.6, confidence interval slopes of 0.934 to 0.986 and confidence interval
intercepts of -0.1 to 2.1. |
| | Sensitivity: The detection limit was 2 mg/L. |
| | Serum vs. Plasma: A study was performed by running CRP determinations on
22 paired samples drawn from the same patients in serum and heparin plasma
tubes. The use of plasma was confirmed in a matrix comparison study using
the paired t-test for means: Range: 7 to 96 mg/L (serum), t-Statistic = 0.13, t-
Critical value 2.08 at a = 0.05, not statistically significant. |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data also
indicate substantial equivalence to the predicate device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alfa Wassermann Diagnostic Technologies, LLC c/o Mr. Dennis Taschek Vice President, Reagent and Instrument Technology 4 Henderson Drive West Caldwell, NY 07006
JAN 3 0 2009
K083040 Re:
Trade Name: S-Test C-Reactive Protein (CRP) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immuno-logical test system Regulatory Class: Class II Product Codes: DCN Dated: January 8, 2009 Received: January 9, 2009
Dear Mr. Taschek:
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).
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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). 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/dsma/dsmamain.html.
Sincerely yours,
Coz. C. H.
Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indication for Use
510(k) Number (if known): K083040
Device Name:
S-Test C-Reactive Protein (CRP)
Indication For Use:
The S-Test C-Reactive Protein Reagent Cartridge is intended for the quantitative determination of C-reactive protein concentration in serum or heparin plasma using the S40 Clinical Analyzer. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
L Prescription Use (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Carol L. Bensen
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K083040