(347 days)
Not Found
No
The summary describes a photometric chemical assay for albumin and does not mention any AI or ML components.
No
The device is an in vitro diagnostic reagent used for the quantitative determination of albumin, which aids in diagnosis and treatment, but it does not directly provide therapy or treatment.
Yes
This device is intended for the quantitative determination of albumin concentration in serum or heparin plasma, and these measurements are used in the diagnosis and treatment of various diseases primarily involving the liver or kidneys. The "Intended Use" explicitly states "For in vitro diagnostic use only."
No
The device is a reagent cartridge used with a clinical analyzer, which are physical components and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "For in vitro diagnostic use only." It also describes the intended use as the "quantitative determination of albumin concentration in serum or heparin plasma," which is a diagnostic measurement performed outside of the body.
- Device Description: Describes the device as an "in vitro diagnostic determination of ALB in serum or heparin plasma."
- Intended User/Care Setting: Specifies use in "clinical laboratories or physician office laboratories," which are typical settings for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
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.
Product codes
CIX
Device Description
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.
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 the S-Test ALB included precision, accuracy, and sensitivity data.
Precision: In testing conducted at three ALB levels for 22 days, the within-run CV ranged from 1.8 to 2.0%, and total CV ranged from 4.7 to 5.6%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CVs ranged from 0.6 to 2.5% and total CVs ranged from 0.8 to 2.8%.
Accuracy: In the correlation study, 92 samples with ALB values ranging from 0.7 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 a correlation coefficient of 0.961, a standard error estimate of 0.24 a confidence interval slope of 0.873 to 0.982, and a confidence interval intercept of 0.05 to 0.51. In patient correlation studies at four separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients ranged from 0.987 to 0.994, standard error estimates of 0.12 to 0.19, confidence interval slopes of 0.942 to 1.040, and a confidence interval intercept of -0.27 to 0.09.
Sensitivity: The detection limit was 0.4 g/dL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Precision (CV: 0.6-2.5% within-run, 0.8-2.8% total), Accuracy (correlation coefficient: 0.961, 0.987-0.994), Sensitivity (detection limit: 0.4 g/dL).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, LLC
4 Henderson Drive
West Caldwell, NJ 07006 |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dennis Taschek
Phone: 973-852-0177
Fax: 973-852-0237 |
| Date Summary
Prepared: | July 7, 2008 |
| Device: | Trade Name: S-Test ALB (21 C.F.R. § 862.1035, Product code CIX)
Classification: Class II
Common/Classification Name: Albumin test systems |
| Predicate
Devices: | Manufacturers for analyzer/reagent system predicates are:
- ACE plus ISE/ Clinical Chemistry System
ACE Albumin Reagent (K931786) - Olympus AU640 Clinical Chemistry Analyzer
Albumin Reagent (K961274) - Piccolo® xpress Chemistry Analyzer
Albumin Reagent (K942782) |
| Device
Description: | 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. |
| Intended Use: | 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. |
| Technological
Characteristics: | 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 active
agent. |
| 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-run
CV ranged from 1.8 to 2.0%, and total CV ranged from 4.7 to 5.6%. In
precision studies at three separate Physician Office Laboratory (POL) sites and
in-house over five days, the within-run CVs ranged from 0.6 to 2.5% and total
CVs ranged from 0.8 to 2.8%. |
| | Accuracy: In the correlation study, 92 samples with ALB values ranging from
0.7 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 a
correlation coefficient of 0.961, a standard error estimate of 0.24 a confidence
interval slope of 0.873 to 0.982, and a confidence interval intercept of 0.05 to
0.51. In patient correlation studies at four separate POL sites using the S40
Clinical Analyzer and a comparative method, least-squares regression analysis
yielded correlation coefficients ranged from 0.987 to 0.994, standard error
estimates of 0.12 to 0.19, confidence interval slopes of 0.942 to 1.040, and a
confidence 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 also
indicate 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