(108 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the S-Test CRP Reagent cartridge, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Metric | Reported Device Performance |
|---|---|---|
| Precision | Within-run CV (Clinical Lab) | Ranged from 1.1% to 3.0% |
| Total CV (Clinical Lab) | Ranged from 2.3% to 4.3% | |
| Within-run CV (Physician Office Lab - POL) | Ranged from 1.0% to 7.5% | |
| Total CV (Physician Office Lab - POL) | Ranged from 1.5% to 7.5% | |
| Accuracy | Correlation coefficient (R-value) | 0.995 (for 95 samples with CRP values 5-91 mg/L) |
| Standard error estimate | 2.1 (for 95 samples with CRP values 5-91 mg/L) | |
| Confidence interval slope | 0.961 to 1.004 (for 95 samples with CRP values 5-91 mg/L) | |
| Confidence interval intercept | 0.4 to 1.6 (for 95 samples with CRP values 5-91 mg/L) | |
| Correlation coefficient (POL sites) | 0.997 to 0.998 | |
| Standard error estimate (POL sites) | 1.5 to 1.6 | |
| Confidence interval slopes (POL sites) | 0.934 to 0.986 | |
| Confidence interval intercepts (POL sites) | -0.1 to 2.1 | |
| Sensitivity | Detection Limit | 2 mg/L |
| Matrix Comparison | Statistical significance (Serum vs. Heparin Plasma) | Paired t-test for means: t-Statistic = 0.13, t-Critical value 2.08 at α = 0.05, not statistically significant. This indicates no significant difference between serum and heparin plasma samples for CRP determination over a range of 7 to 96 mg/L. |
Study Information
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Sample size used for the test set and the data provenance:
- Clinical Lab Accuracy Study: 95 samples with CRP values ranging from 5 to 91 mg/L.
- POL Site Accuracy Studies: The exact number of samples is not specified for each POL site, but it states "patient correlation studies at three separate POL sites."
- Precision Studies: Not explicitly stated as a "test set" in the same way as accuracy, but samples were tested at "three CRP levels for 24 days" in the clinical lab and "at three separate Physician Office Laboratory (POL) sites and in-house over five days."
- Serum vs. Plasma Study: 22 paired samples (serum and heparin plasma from the same patients).
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the mention of "in-house" and "three separate Physician Office Laboratory (POL) sites" suggests data collected through internal R&D and clinical settings, likely prospective for the specific studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in-vitro diagnostic (IVD) for quantitative measurement, not an imaging or diagnostic device requiring human expert interpretation for "ground truth." The "ground truth" for its performance evaluation comes from a comparative method (predicate device or established clinical method) rather than human experts.
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Adjudication method for the test set:
- Not applicable as the "ground truth" is established by a comparative method, not human interpretation requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. This type of study is relevant for devices that involve human interpretation of images or other data, where the AI assists the human reader. The S-Test CRP Reagent cartridge is an automated quantitative assay.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented (precision, accuracy, sensitivity) are for the standalone algorithm/device (S-Test CRP reagent cartridge on the S40 Clinical Analyzer) measuring CRP levels. There is no human interpretation component in the measurement process itself.
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The type of ground truth used:
- The "ground truth" for the accuracy studies was established by a comparative method (likely either the Olympus AU640 Clinical Chemistry Analyzer CRP Latex Reagent, which is the predicate for the system, or another clinically accepted method). The text states: "...assayed on the S40 Clinical Analyzer using S-Test CRP (y) and a comparative method (x)."
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The sample size for the training set:
- The document describes performance data for the final device (test set), not the training set used during development. Therefore, the sample size for the training set is not provided in this summary.
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How the ground truth for the training set was established:
- Since the training set size is not provided, the method for establishing its ground truth is also not specified in this document. Assuming a typical IVD development process, the training data would also likely have been compared against a reference or comparative method.
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JAN 3 0 2009
510(k) SUMMARY
| 510(k) Owner: | Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006 |
|---|---|
| Contact: | Dennis TaschekPhone: 973-852-0177Fax: 973-852-0237 |
| Date SummaryPrepared: | October 13, 2008 |
| Device: | Trade Name:S-Test CRP Reagent cartridge |
| Classification:Class II | |
| Common/ClassificationName:CRP: C-reactive protein test system(21 C.F.R. § 866.5270), Product code DCN | |
| PredicateDevice: | Manufacturers for analyzer/reagent system predicate is:Olympus AU640 Clinical Chemistry AnalyzerCRP Latex Reagent (K961274) |
| DeviceDescription: | The S-Test C-Reactive Protein (CRP) reagent cartridge, used with the S40Clinical Analyzer, is intended for quantitative in vitro diagnostic determinationof CRP in serum or heparin plasma based on a photometric test measuring theagglutination that results when an antigen-antibody reaction occurs betweenCRP in the sample and anti-CRP mouse monoclonal antibody-coated latex. |
| Intended Use: | The S-Test C-Reactive Protein Reagent Cartridge is intended for thequantitative determination of C-reactive protein concentration in serum orheparin plasma using the S40 Clinical Analyzer. Measurement of C-reactiveprotein aids in evaluation of the amount of injury to body tissues. This test isintended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only. |
| TechnologicalCharacteristics: | The S-Test CRP Reagent is contained in a bi-reagent cartridge. Reagent 1contains: 2-amino-2-hydroxymethyl-1,3-propanediol buffer (pH 8.5, 20mmol/L). Reagent 2 contains: anti-human C-reactive mouse protein andmonoclonal antibody-coated latex (2 mg/mL). |
| PerformanceData: | Performance data on S-Test CRP reagent included precision, accuracy, andsensitivity data. |
| Precision: In testing at three CRP levels for 24 days, the within-run CV rangedfrom 1.1 to 3.0% and total CV ranged from 2.3 to 4.3%. In precision studies atthree separate Physician Office Laboratory (POL) sites and in-house over fivedays, the within-run CV ranged from 1.0 to 7.5% and total CV ranged from 1.5to 7.5%. | |
| Accuracy: In the correlation study, 95 samples with CRP values ranging from5 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 acorrelation coefficient of 0.995, a standard error estimate of 2.1, a confidenceinterval slope of 0.961 to 1.004, and a confidence interval intercept of 0.4 to1.6. In patient correlation studies at three separate POL sites using the S40Clinical Analyzer and a comparative method, least-squares regression analysisyielded correlation coefficients of 0.997 to 0.998, standard error estimates of1.5 to 1.6, confidence interval slopes of 0.934 to 0.986 and confidence intervalintercepts 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 on22 paired samples drawn from the same patients in serum and heparin plasmatubes. The use of plasma was confirmed in a matrix comparison study usingthe 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 alsoindicate 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
§ 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).