(347 days)
The S-Test Albumin Reagent is intended for the quantitative determination of albumin concentration in serum or heparin plasma using the S40 Clinical Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test albumin (ALB) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALB in serum or heparin plasma based on a photometric test measuring the formation of a bluish-green complex from ALB and bromcresol green.
The S-Test ALB device, used with the S40 Clinical Analyzer, is an in vitro diagnostic intended for the quantitative determination of albumin concentration in serum or heparin plasma. The device's performance was evaluated through precision, accuracy, and sensitivity studies.
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Precision | Not explicitly stated as acceptance criteria, but based on the reported data, the device should exhibit consistent reproducibility. | In-house (22 days, three ALB levels): Within-run CV ranged from 1.8 to 2.0%; total CV ranged from 4.7 to 5.6%. |
| POL sites (three sites, five days): Within-run CVs ranged from 0.6 to 2.5%; total CVs ranged from 0.8 to 2.8%. | ||
| Accuracy | Not explicitly stated as acceptance criteria, but based on the reported data, the device should demonstrate a strong correlation with a comparative method and acceptable regression analysis parameters. | Correlation study (92 samples, ALB 0.7 to 6.8 g/dL): Correlation coefficient (r) = 0.961; standard error estimate (SEE) = 0.24; confidence interval slope = 0.873 to 0.982; confidence interval intercept = 0.05 to 0.51. |
| Patient correlation studies (four POL sites): Correlation coefficients ranged from 0.987 to 0.994; standard error estimates ranged from 0.12 to 0.19; confidence interval slopes ranged from 0.942 to 1.040; confidence interval intercept ranged from -0.27 to 0.09. | ||
| Sensitivity | Not explicitly stated as acceptance criteria, but refers to the lowest detectable concentration. | The detection limit was 0.4 g/dL. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Accuracy (Correlation Study): 92 samples.
- Sample Size for Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate Physician Office Laboratory (POL) sites, implying multiple patient samples from each site.
- Sample Size for Precision: Three ALB levels for 22 days (in-house) and three separate POL sites over five days. The number of individual samples per level or site is not specified.
- Data Provenance: The studies were conducted at "three separate Physician Office Laboratory (POL) sites" and "four separate POL sites," along with "in-house" testing. This suggests a mix of internal testing and external validation in real-world clinical settings (Physician Office Laboratories). The country of origin is not explicitly stated, but given the submission is to the FDA, it is likely the studies were conducted in the United States or under comparable regulatory standards. The data is prospective as it describes the performance of the device in studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for this device is based on quantitative measurements of albumin concentration, not expert interpretation of qualitative data (e.g., images). Therefore, clinical experts (like radiologists) for establishing "ground truth" in the traditional sense are not applicable here. The "ground truth" is established by a "comparative method" or a reference method for albumin measurement.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used for qualitative assessments where there might be disagreement among human readers. Since the performance studies involve quantitative measurements of albumin concentration against a comparative method, adjudication methods are not relevant or described. The comparison is between the S-Test ALB measurements and the measurements from the comparative method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for tasks involving interpretation (e.g., radiology). The S-Test ALB is a clinical analyzer for quantitative biochemical measurements, not an image interpretation or diagnostic aid for human readers.
6. Standalone Performance Study
Yes, a standalone study was done. The performance data presented (precision, accuracy, sensitivity) directly reflects the performance of the S-Test ALB reagent cartridge used with the S40 Clinical Analyzer as a standalone system. The results are based on the device's measurements compared to a "comparative method," which serves as the reference, rather than comparing it to human interpretation.
7. Type of Ground Truth Used
The ground truth used is quantitative measurements from a comparative method. For accuracy studies, the S40 Clinical Analyzer using S-Test ALB (y) was compared against a "comparative method" (x) for albumin determination. This implies that results from an established, independently validated method were used as the reference standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" or "training data" for the device. Clinical analyzers like the S40 Clinical Analyzer with S-Test ALB typically rely on established chemical reactions and calibration procedures rather than machine learning models that are "trained" on a dataset in the same way an AI algorithm would be. The "training" in this context would refer to instrument calibration and reagent validation.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of an AI algorithm is not applicable here. The "training" for a clinical analyzer system would involve calibration using known standards according to the manufacturer's protocols and quality control procedures. These standards would have their values established through highly accurate and traceable reference methods. The document does not describe the specific calibration or quality control protocols used, but these are standard practices for in vitro diagnostic devices.
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510(k) Summary
S40 Clinical Analyzer
S-Test ALB
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072143
510(k) SUMMARY
JUL 1 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: | July 7, 2008 |
| Device: | Trade Name: S-Test ALB (21 C.F.R. § 862.1035, Product code CIX)Classification: Class IICommon/Classification Name: Albumin test systems |
| PredicateDevices: | Manufacturers for analyzer/reagent system predicates are:1. ACE plus ISE/ Clinical Chemistry SystemACE Albumin Reagent (K931786)2. Olympus AU640 Clinical Chemistry AnalyzerAlbumin Reagent (K961274)3. Piccolo® xpress Chemistry AnalyzerAlbumin Reagent (K942782) |
| DeviceDescription: | The S-Test albumin (ALB) reagent cartridge used with the S40 ClinicalAnalyzer is intended for quantitative in vitro diagnostic determination of ALBin serum or heparin plasma based on a photometric test measuring theformation of a bluish-green complex from ALB and bromcresol green. |
| Intended Use: | The S-Test Albumin Reagent is intended for the quantitative determination ofalbumin concentration in serum or heparin plasma using the S40 ClinicalAnalyzer. Albumin measurements are used in the diagnosis and treatment ofnumerous diseases involving primarily the liver or kidneys. This test isintended for use in clinical laboratories or physician office laboratories. For invitro diagnostic use only. |
| TechnologicalCharacteristics: | The S-Test ALB is a bi-reagent cartridge. Reagent 1 and Reagent 2 contain:bromcresol green, succinic acid buffer (pH 4.25), and nonionic surface activeagent. |
| Performance | Performance data on the S-Test ALB included precision, accuracy, and |
| Data: | sensitivity data. |
| Precision: In testing conducted at three ALB levels for 22 days, the within-runCV ranged from 1.8 to 2.0%, and total CV ranged from 4.7 to 5.6%. Inprecision studies at three separate Physician Office Laboratory (POL) sites andin-house over five days, the within-run CVs ranged from 0.6 to 2.5% and totalCVs ranged from 0.8 to 2.8%. | |
| Accuracy: In the correlation study, 92 samples with ALB values ranging from0.7 to 6.8 g/dL were assayed on the S40 Clinical Analyzer using S-Test ALB(y) and a comparative method (x). Least-squares regression analysis yielded acorrelation coefficient of 0.961, a standard error estimate of 0.24 a confidenceinterval slope of 0.873 to 0.982, and a confidence interval intercept of 0.05 to0.51. In patient correlation studies at four separate POL sites using the S40Clinical Analyzer and a comparative method, least-squares regression analysisyielded correlation coefficients ranged from 0.987 to 0.994, standard errorestimates of 0.12 to 0.19, confidence interval slopes of 0.942 to 1.040, and aconfidence interval intercept of -0.27 to 0.09. | |
| Sensitivity: The detection limit was 0.4 g/dL. | |
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data alsoindicate substantial equivalence to the predicate devices. |
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Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072143
S40 Clinical Analyzer S-Test ALB
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Image /page/2/Picture/0 description: The image shows the logo and text for the Department of Health & Human Services. The logo is on the left side of the image. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the right side of the image. The text is in all caps.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Alfa Wasserman Diagnostic Technology, Inc. c/o Mr. Dennis Taschek VP, Reagent & Instrument Technologies 4 Henderson Drive West Caldwell, NJ 07006
JUL 1 4 2008
Re: K072143
Trade Name: S-Test Albumin (ALB) Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin Test System Regulatory Class: Class II Product Codes: CIX Dated: July 7, 2008 Received: July 9, 2008
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 (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.
Séan 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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Indication for Use
510(k) Number (if known): K072143
Device Name: S-Test Albumin (ALB)
The S-Test Albumin Reagent is intended for the quantitative Indications For Use: determination of albumin concentration in serum or heparin plasma using the S40 Clinical Analyzer. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (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 (OIVD)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072143
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.