(329 days)
The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
The S-Test alkaline phosphatase (ALP) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALP activity in serum or heparin plasma based on an enzymatic photometric test using p -nitrophenyl phosphate as a substrate.
The S-Test amylase (AMY) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of amylase activity in serum or heparin plasma based on an enzymatic photometric test using 2-chloro-4-nitrophenyl-alpha-galactopyranosyl maltoside (Gal-G2-CNP) as a substrate.
The S-Test aspartate aminotransferase (AST) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of AST in serum or heparin plasma based on an enzymatic photometric test using L-aspartate and alpha-ketoglutarate as substrates.
Here's a summary of the acceptance criteria and study details for the S-Test ALP, AMY, and AST reagent cartridges, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the reported performance, which demonstrates substantial equivalence to predicate devices. The study compares the performance of the S-Test reagents on the S40 Clinical Analyzer against comparison methods.
| Metric | Acceptance Criteria (Implied) | Reported Performance (S-Test ALP) | Reported Performance (S-Test AMY) | Reported Performance (S-Test AST) |
|---|---|---|---|---|
| Precision | Comparable to predicate devices and acceptable for intended use. | In-house (22 days, 3 ALP levels): Within-run CV: 2.2-3.5%; Total CV: 5.4-5.7%. POL sites (5 days, 3 ALP levels): Within-run CV: 1.5-4.4%; Total CV: 1.5-4.9%. | In-house (22 days, 3 AMY levels): Within-run CV: 1.7-2.4%; Total CV: 6.4-8.2%. POL sites (5 days, 3 AMY levels): Within-run CV: 1.0-6.4%; Total CV: 1.0-6.6%. | In-house (22 days, 3 AST levels): Within-run CV: 0.8-2.5%; Total CV: 4.4-4.9%. POL sites (5 days, 3 AST levels): Within-run CV: 0.8-4.8%; Total CV: 0.9-7.0%. |
| Accuracy | High correlation with comparison methods. | Correlation Study (180 samples, 28-733 U/L): Correlation coefficient: 0.997; Standard error estimate: 10.9; CI slope: 0.929-1.009; CI intercept: -4.43-2.02. POL sites (patient correlation): Correlation coefficients: 0.996-0.998; Standard error estimates: 10.4-14.3; CI slopes: 0.963-1.011; CI intercepts: -2.5-15.6. | Correlation Study (196 samples, 9-1461 U/L): Correlation coefficient: 0.997; Standard error estimate: 21.0; CI slope: 0.932-1.005; CI intercept: 0.56-5.81. POL sites (patient correlation): Correlation coefficients: 0.997; Standard error estimates: 35.6-37.0; CI slopes: 0.914-0.960; CI intercepts: -7.4-21.6. | Correlation Study (177 samples, 10-333 U/L): Correlation coefficient: 0.998; Standard error estimate: 4.5; CI slope: 0.986-1.042; CI intercept: -1.75-0.09. POL sites (patient correlation): Correlation coefficients: 0.998; Standard error estimates: 6.3-6.7; CI slopes: 1.041-1.110; CI intercepts: -7.7-4.9. |
| Sensitivity | Detection limits suitable for clinical use. | Detection limit: 20 U/L. | Detection limit: 8 U/L. | Detection limit: 8 U/L. |
2. Sample Sizes Used for the Test Set and Data Provenance
- S-Test ALP:
- Accuracy (Correlation Study): 180 samples.
- Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites, implying a collection of patient samples.
- S-Test AMY:
- Accuracy (Correlation Study): 196 samples.
- Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites.
- S-Test AST:
- Accuracy (Correlation Study): 177 samples.
- Accuracy (Patient Correlation Studies): Not explicitly stated, but conducted at four separate POL sites.
Data Provenance: The studies were conducted "in-house" and at "three/four separate Physician Office Laboratories (POL) sites." This suggests a mix of laboratory and real-world clinical settings, likely within the US given the submission to the FDA. The data is presented as if it's from prospective collection for the study, as it involved assaying samples on the new device and a comparison method.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the summary. The study relies on "comparison methods" to establish the reference values for the samples, rather than human expert interpretation of raw data. The performance is assessed by comparing the S-Test results to these established comparison methods.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth is established by "comparison methods" (presumably other validated IVD assays), not by human interpretation requiring adjudication.
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
An MRMC comparative effectiveness study was not performed. This submission is for an in vitro diagnostic (IVD) reagent cartridge for quantitative determination of analytes, not a device requiring human interpretation of images or other qualitative data that would benefit from an MRMC study with human readers (or AI assistance).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study is inherently a standalone performance evaluation of the reagent cartridges used with the S40 Clinical Analyzer. The "algorithm" here is the enzymatic photometric test and the analyzer's processing of the photometric data to produce a quantitative result. The performance data presented (precision, accuracy, sensitivity) directly reflects the standalone capabilities of the device without human intervention in the result generation process itself.
7. The type of ground truth used
The ground truth was established by "comparison methods." This refers to existing, legally marketed, and presumably validated IVD assays for ALP, AMY, and AST. The performance of the S-Test reagents was compared directly to the results obtained from these comparison methods on the same samples.
8. The Sample Size for the Training Set
This information is not provided. As these are chemical reagents and an analyzer system, there isn't a "training set" in the sense of machine learning algorithms that learn from data. The reagents and analyzer system are developed and validated through chemical and engineering principles.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a "training set" in the context of this IVD device. The development and validation of such a system would involve extensive analytical characterization (e.g., linearity, interference, stability) and verification against known standards and reference materials, rather than a data-driven "ground truth" for training.
{0}------------------------------------------------
510(k) SUMMARY
JUN 2 6 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 ALP; S-Test AMY; S-Test AST Reagentcartridge(21 C.F.R. § 862.1050, Product code CJI; 21C.F.R. § 862.1070, Product code JFJ; 21 C.F.R.§ 862.1100, Product code CIT) |
| Classification: | Class II | |
| Common/ClassificationName: | Alkaline phosphatase; amylase; aspartateaminotransferase test systems | |
| PredicateDevices | Manufacturers for analyzer/reagent system predicates are: | |
| 1. | ACE plus ISE/ Clinical Chemistry System | |
| ACE Alkaline Phosphatase Reagent (K931786) | ||
| ACE Amylase Reagent (K931786) | ||
| ACE Aspartate Aminotransferase Reagent (K931786) | ||
| 2. | Olympus AU640 Clinical Chemistry Analyzer | |
| Alkaline Phosphatase Reagent (K961274) | ||
| Amylase Reagent (K961274) | ||
| Aspartate Aminotransferase Reagent (K961274) | ||
| 3. | Piccolo® xpress Chemistry Analyzer | |
| Alkaline Phosphatase Reagent (K942782) | ||
| Amylase Reagent (K942782) | ||
| Aspartate Aminotransferase Reagent (K942782) | ||
| Device Description: | The S-Test alkaline phosphatase (ALP) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of ALP activity in serum or heparin plasma based on an enzymatic photometric test using p -nitrophenyl phosphate as a substrate. | |
| The S-Test amylase (AMY) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of amylase activity in serum or heparin plasma based on an enzymatic photometric test using 2-chloro-4-nitrophenyl-α-galactopyranosyl maltoside (Gal-G2-CNP) as a substrate. | ||
| The S-Test aspartate aminotransferase (AST) reagent cartridge used with the S40 Clinical Analyzer is intended for quantitative in vitro diagnostic determination of AST in serum or heparin plasma based on an enzymatic photometric test using L-aspartate and α-ketoglutarate as substrates. | ||
| Intended Use: | The S-Test Alkaline Phosphatase Reagent is intended for the quantitative determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | |
| The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | ||
| The S-Test Aspartate Aminotransferase Reagent is intended for the quantitative determination of aspartate aminotransferase activity in serum or heparin plasma using the S40 Clinical Analyzer. Aspartate aminotransferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. | ||
| TechnologicalCharacteristics: | The S-Test ALP is a bi-reagent cartridge. Reagent 1 is ethyl amino ethanolbuffer and magnesium chloride. Reagent 2 is p-nitrophenyl phosphate (46mmol/L).The S-Test AMY is a bi-reagent cartridge. Reagent 1 contains: sodiumchloride, calcium chloride, and Good's buffer (pH 6.0). Reagent 2 contains: α-2-chloro-4-nitrophenyl galactopyranosyl maltoside, potassium thiocyanate, andGood's buffer (pH 6.0).The S-Test AST reagent is a bi-reagent cartridge. Reagent 1 contains:nicotinamide-adenine dinucleotide (reduced form), malate dehydrogenase(derived from Thermus), 2-amino-2-hydroxymethyl-1,3-propanediol buffer(pH 7.8, 30°C), and L-aspartic acid. Reagent 2 contains: L-aspartic acid, α-ketoglutaric acid, and 2-amino-2-hydroxymethyl-1,3-propanediol buffer (pH7.8, 30°C). | |
| PerformanceData: | Performance data on the S-Test ALP, S-Test AMY, and S-Test AST, andincluded precision, accuracy, and sensitivity data.S-Test ALPPrecision: In testing conducted at three ALP levels for 22 days, the within-runCV ranged from 2.2 to 3.5%, and total CV ranged from 5.4 to 5.7%. Inprecision studies at three separate Physician Office Laboratories (POL) sitesand in-house over five days, the within-run CV ranged from 1.5 to 4.4%, andthe total CV ranged from 1.5 to 4.9%.Accuracy: In the correlation study, 180 samples with ALP values rangingfrom 28 to 733 U/L were assayed on the S40 Clinical Analyzer using S-Test-ALP reagent and a comparison method. Least-squares regression analysisyielded a correlation coefficient of 0.997, a standard error estimate of 10.9, aconfidence interval slope of 0.929 to 1.009, and a confidence interval interceptof -4.43 to 2.02. In patient correlation studies at four separate POL sites usingthe S40 Clinical Analyzer and a comparative method, least-squares regressionanalysis yielded correlation coefficients ranging from 0.996 to 0.998, standarderror estimates of 10.4 to 14.3, confidence interval slopes of 0.963 to 1.011,and confidence interval intercepts of -2.5 to 15.6.Sensitivity: The detection limit was 20 U/L.S-Test AMYPrecision: In testing at three amylase levels for 22 days, the within-run CVranged from 1.7 to 2.4%, and total CV ranged from 6.4 to 8.2%. In precisionstudies at three separate POL sites and in-house over five days, the within-runCV ranged from 1.0 to 6.4%, and the total CV ranged from 1.0 to 6.6%Accuracy: In the correlation study, 196 samples with amylase values rangingfrom 9 to 1461 U/L were assayed on the S40 Clinical Analyzer using S-TestAmylase and a comparison method. Least-squares regression analysis yielded | |
| a correlation coefficient of 0.997, a standard error estimate of 21.0, aconfidence interval slope of 0.932 to 1.005, and a confidence interval interceptof 0.56 to 5.81. In patient correlation studies at four separate POL sites usingthe S40 Clinical Analyzer and a comparison method, least-squares regressionanalysis yielded correlation coefficients of 0.997, standard error estimates of35.6 to 37.0, confidence interval slopes of 0.914 to 0.960, and confidenceinterval intercepts of -7.4 to 21.6. | ||
| Sensitivity: The detection limit was 8 U/L.S-Test AST | ||
| Precision: In testing at three AST levels for 22 days, the within-run CV rangedfrom 0.8 to 2.5%, and total CV ranged from 4.4 to 4.9%. In precision studiesat three separate POL sites and in-house over five days, the within-run CVranged from 0.8 to 4.8%, and the total CV ranged from 0.9 to 7.0%. | ||
| Accuracy: In the correlation study, 177 samples with AST values rangingfrom 10 to 333 U/L were assayed using S-Test AST and a comparison method.Least-squares regression analysis yielded a correlation coefficient of 0.998, astandard error estimate of 4.5, a confidence interval slope of 0.986 to 1.042,and confidence interval intercept of -1.75 to 0.09. In patient correlation studiesat four separate POL sites over five days using the S40 Clinical Analyzer and acomparison method, least-squares regression analysis yielded correlationcoefficients of 0.998, standard error estimates of 6.3 to 6.7, confidence intervalslopes of 1.041 to 1.110, and confidence interval intercepts of -7.7 to 4.9. | ||
| Sensitivity: The detection limit was 8 U/L. | ||
| Conclusions: | Based on the foregoing data, the device is safe and effective. These data alsoindicate substantial equivalence to the predicate devices. |
{1}------------------------------------------------
:
{2}------------------------------------------------
{3}------------------------------------------------
:
{4}------------------------------------------------
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 2 6 2008
Alfa Wassermann Diagnostic Technologies, Inc. c/o Mr. Daivd Slavin Vice President. Quality and Regulatory Affairs 4 Henderson Drive West Caldwell, NJ 07006
Rc: K072142
Trade/Device Name: S Test Alkaline Phosphatase (ALP) Reagent cartridge, S Test Amylase (AMY) Reagent cartridge and S Test Aspartate Aminotransferase (AST) Reagent cartridge Regulation Number: 21 CFR 862.1050 Regulation Name: Alkaline Phosphatase or isoenzymes test system Regulatory Class: Class II Product Code: CKF, CIJ, CIT 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).
{5}------------------------------------------------
Page 2 -
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/cdrl/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jéan 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
{6}------------------------------------------------
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072142
S40 Clinical Analyzer S-Test ALP S-Test AMY S-Test AST
Indications for Use
510(k) Number K072142 (if known):
Device Name: S-Test Alkaline Phosphatase (ALP)
The S-Test Alkaline Phosphatase Reagent is intended for the quantitative Indications for Use: determination of alkaline phosphatase activity in serum or heparin plasma using the S40 Clinical Analyzer. Measurements of alkaline phosphatase are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.
Prescription Use X (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 In Vitro Diagnostic Device Evaluation and Safety (OIVD)
SAN A. pedini
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K079149
June 3, 2008
CONFIDENTIAL
{7}------------------------------------------------
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072142
S40 Clinical Analyzer S-Test ALP S-Test AMY S-Test AST
Indications for Use
510(k) Number K072142 (if known):
Device Name: S-Test Amylase (AMY)
Indications for Use: The S-Test Amylase Reagent is intended for the quantitative determination of amylase activity in serum or heparin plasma using the S40 Clinical Analyzer. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas). 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 (ODE)
Division Sign-Off
LAVP acting
CONFIDENTIAL
Office of In Vitro Diagnostic
Device Evaluation and Safety
L 518/49
June 3, 2008
{8}------------------------------------------------
Alfa Wassermann Diagnostic Technology, Inc. 510(k) Submission K072142
S40 Clinical Analyzer S-Test ALP S-Test AMY S-Test AST
Indications for Use
| 510(k) Number(if known): | K072142 |
|---|---|
| Device Name: | S-Test Aspartate Aminotransferase (AST) |
| Indications for Use: | The S-Test Aspartate Aminotransferase Reagent is intended for thequantitative determination of aspartate aminotransferase activity in serumor heparin plasma using the S40 Clinical Analyzer. Aspartateaminotransferase measurements are used in the diagnosis and treatment ofcertain types of liver and heart disease. This test is intended for use inclinical laboratories or physician office laboratories. For in vitrodiagnostic 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 (ODE)
luation (ODE)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
June 3, 2008
CONFIDENTIAL
§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.