(307 days)
The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Calcium (CA) reagent cartridge, used with the S40 Clinical Analyzer, is intended for quantitative in vitro diagnostic determination of CA in serum or heparin plasma based on a photometric test measuring the formation of a reddish-purple complex under strong alkaline conditions.
The provided 510(k) summary describes the acceptance criteria and the study that proves the device meets those criteria for the S-Test CA Reagent cartridge, used for quantitative determination of calcium in serum or heparin plasma.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The summary does not explicitly state "acceptance criteria" as pass/fail thresholds. Instead, it presents performance data for precision, accuracy, and sensitivity, which are implicitly the criteria for demonstrating substantial equivalence.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision | Demonstrated low variability | Reference Lab (21 days): - Within-run CV: 1.1 to 1.2% (3 CA levels) - Total CV: 1.6 to 2.2% |
| POL Sites (5 days): - Within-run CV: 0.4 to 3.9% - Total CV: 0.7 to 4.3% | ||
| Accuracy | High correlation with comparison method; low error | Correlation Study (181 samples): - Correlation Coefficient: 0.978 - Standard Error Estimate: 0.4 - Confidence Interval Slope: 0.950 to 1.003 - Confidence Interval Intercept: -0.30 to 0.17 |
| Patient Correlation (4 POL sites): - Correlation Coefficients: 0.929 to 0.965 - Standard Error Estimates: 0.49 to 0.68 - Confidence Interval Slopes: 0.833 to 1.048 - Confidence Interval Intercepts: -0.62 to 1.54 | ||
| Sensitivity | Low detection limit | Detection Limit: 2.3 mg/dL |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: For accuracy/correlation studies, 181 samples were used in the main correlation study, ranging from 2.4 to 14.5 mg/dL CA values.
- Data Provenance: The document does not explicitly state the country of origin. It mentions studies conducted "at three separate Physician Office Laboratory (POL) sites and in-house" as well as "four separate POL sites," suggesting these were conducted within the US, where the applicant (Alfa Wassermann Diagnostic Technology, LLC) is located. The studies appear to be prospective as they involve assaying samples on the S40 Clinical Analyzer and a comparison method for performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is a clinical chemistry device for quantitative measurement. The "ground truth" is established by a comparison method, which is another established clinical analyzer or laboratory method for measuring calcium. Experts are not typically used to establish ground truth in this context; rather, the accuracy of the new device is validated against the results of a recognized, validated reference method. The document does not specify details about the "comparison method" used, such as its specific identity or the qualifications of those operating it beyond being a "comparison method."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Adjudication methods are typically employed in studies where human interpretation of results is involved (e.g., radiology image interpretation). For quantitative chemistry assays, the comparison is made directly between the numerical output of the new device and the comparison method.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
N/A. This is a quantitative in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone diagnostic test system (reagent cartridge + analyzer). The performance data presented (precision, accuracy, sensitivity) directly reflects the performance of the "algorithm" and instrument without human interpretive subjectivity in the measurement itself. Human action involves operating the instrument and interpreting the numerical output, but the measurement itself is automated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the accuracy studies was established by a comparison method (another clinical analyzer or laboratory assay) that is presumably already clinically validated and accepted.
8. The sample size for the training set
N/A. This 510(k) summary describes a traditional in vitro diagnostic device, not a machine learning model that requires a "training set." The device's performance is based on its chemical and photometric principles and calibration, not on data-driven training.
9. How the ground truth for the training set was established
N/A. (See point 8).
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510(k) SUMMARY
JUN 2 4 2008
| 510(k) Owner: | Alfa Wassermann Diagnostic Technology, LLC4 Henderson DriveWest Caldwell, NJ 07006 | |
|---|---|---|
| Contact: | Dennis TaschekPhone: 973-852-0177Fax: 973-852-0237 | |
| Date SummaryPrepared: | June 19, 2008 | |
| Device: | Trade Name: | S-Test CA Reagent cartridge |
| Common/Classification Name: | Calcium Test System(21 C.F.R. § 862.1145)Product Code CJY | |
| Classification: | Class II | |
| PredicateDevices: | Manufacturers for analyzer/reagent system predicates are:1. ACE plus ISE/Clinical Chemistry SystemACE Calcium Reagent (K931786)2. Ortho Clinical Diagnostics Fusion Clinical Chemistry AnalyzerCalcium Reagent (K946090)3. Piccolo® xpress Chemistry AnalyzerCalcium Reagent (K942782) | |
| DeviceDescription: | The S-Test Calcium (CA) reagent cartridge, used with the S40 ClinicalAnalyzer, is intended for quantitative in vitro diagnostic determinationof CA in serum or heparin plasma based on a photometric testmeasuring the formation of a reddish-purple complex under strongalkaline conditions. | |
| Intended Use: | The S-Test Calcium Reagent is intended for the quantitativedetermination of calcium concentration in serum or heparin plasmausing the S40 Clinical Analyzer. Calcium measurements are used in thediagnosis and treatment of parathyroid disease, a variety of bonediseases, chronic renal disease, and tetany (intermittent muscularcontractions or spasms). This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic useonly | |
| TechnologicalCharacteristics: | The S-Test CA Reagent is contained in a bi-reagent cartridge. Reagent1 contains monoethanolamine buffer and 8-hydroxyquinoline. Reagent2 contains o-cresolphthalein complexone. | |
| PerformanceData: | Performance data on the S-Test CA included precision, accuracy, andsensitivity data.Precision: In testing conducted at three CA levels for 21 days, thewithin-run CV ranged from 1.1 to 1.2%, and total CV ranged from 1.6to 2.2%. In precision studies at three separate Physician OfficeLaboratory (POL) sites and in-house over five days, the within-run CVranged from 0.4 to 3.9% and total CV ranged from 0.7 to 4.3%.Accuracy: In the correlation study, 181 samples with CA valuesranging from 2.4 to 14.5 mg/dL were assayed on the S40 ClinicalAnalyzer using S-Test CA and a comparison method. Least-squaresregression analysis yielded a correlation coefficient of 0.978, a standarderror estimate of 0.4, a confidence interval slope of 0.950 to 1.003, anda confidence interval intercept of -0.30 to 0.17. In patient correlationstudies at four separate POL sites using the S40 Clinical Analyzer and acomparison method, least-squares regression analysis yielded acorrelation coefficients in the range of 0.929 to 0.965, standard errorestimates of 0.49 to 0.68, confidence interval slopes of 0.833 to 1.048,and confidence interval intercepts of -0.62 to 1.54.Sensitivity: The detection limit was 2.3 mg/dL. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. Thesedata also indicate substantial equivalence to the predicate devices. |
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 4 2008
Alfa Wassermann Diagnostic Technologies, Inc. c/o Mr. Daivd Slavin Vice President, Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
Re: K072356
Trade/Device Name: S Test Calcium Reagent cartridge Regulation Number: 21 CFR 862.1145 Regulation Name: Calcium test system Regulatory Class: Class II Product Code: CJY Dated: June 16, 2008 Received: June 17, 2008
Dear Mr. Slavin:
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 (240) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., 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
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Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072356
S40 Clinical Analyzer S-Test CA
Indications for Use Statement
510(k) Number K072356 (if known):
Device Name:
S-Test Calcium (CA)
Indications for Use: The S-Test Calcium Reagent is intended for the quantitative determination of calcium concentration in serum or heparin plasma using the S40 Clinical Analyzer. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease, and tetany (intermittent muscular contractions or spasms). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT, WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
| Concurrence of CDRH, Office of Device Evaluation (OIVD) | |
|---|---|
| Division/Sign-Off |
Office of in Vitro Diagnostic
Device Evaluation and Safety
June 3, 2008
510(k) K072336
CONFIDENTIAL
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.