The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test High Density Lipoprotein Reagent is intended for the quantitative determination of HDL concentration in serum or heparin plasma using the S40 Clinical Analyzer. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

The S-Test Triglycerides Reagent is intended for the quantitative determination of triglyceride concentration in serum or heparin plasma using the S40 Clinical Analyzer. Triglyceride measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders. This test is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only.

Device Description

The S-Test Cholesterol (CHO), S-Test HDL Cholesterol (HDL) and S-Test Triglycerides (TG) reagent cartridges, used with the S40 Clinical Analyzer, are intended for quantitative in vitro diagnostic determination of CHO, HDL, and TG concentrations in serum or heparin plasma based on a photometric test measuring the formation of reddish purple complexes in coupled enzymatic reactions.

AI/ML Overview

The provided text describes the 510(k) summary for the S-Test Cholesterol (CHO), S-Test High Density Lipoprotein Cholesterol (HDL), and S-Test Triglycerides (TG) reagent cartridges for use with the S40 Clinical Analyzer. This summary outlines the performance data for each test.

Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
S-Test CHO		-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Precision (Within-run CV)	Not explicitly stated as acceptance criteria, but demonstrated to be within acceptable ranges for clinical laboratory assays.	In testing three CHO levels for 22 days, the within-run CV ranged from 0.9% to 1.6%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 0.3% to 2.0%.
Precision (Total CV)	Not explicitly stated as acceptance criteria, but demonstrated to be within acceptable ranges for clinical laboratory assays.	In testing three CHO levels for 22 days, the total CV ranged from 2.2% to 2.6%. In precision studies at three separate POL sites and in-house over five days, the total CV ranged from 0.7% to 2.0%.
Accuracy (Correlation Coefficient)	Not explicitly stated, but high correlation (close to 1) with comparative method is expected.	0.983 (in-house study) and 0.9585 to 0.9969 (POL sites) using least-squares regression analysis against a comparative method.
Accuracy (Confidence Interval Slope)	Not explicitly stated, but expected to be close to 1.	0.942 to 1.014 (in-house study) and 0.868 to 1.056 (POL sites).
Accuracy (Confidence Interval Intercept)	Not explicitly stated, but expected to be close to 0.	-3.8 to 10.8 (in-house study) and -15.7 to 16.2 (POL sites).
Accuracy (Standard Error Estimate)	Not explicitly stated, but low values are preferred.	11.3 (in-house study) and 4.8 to 16.7 (POL sites).
Detection Limit	Not explicitly stated, but a low value is preferred for analytical sensitivity.	7 mg/dL.
Serum vs. Plasma Difference	Difference less than ±5% tolerance limit.	Means for serum (149 mg/dL) and plasma (147 mg/dL) differed by less than ±5%. Serum range: 22 to 249 mg/dL.
S-Test HDL		-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Precision (Within-run CV)	Not explicitly stated as acceptance criteria.	In testing three HDL levels for 23 days, the within-run CV ranged from 2.0% to 2.8%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.2% to 2.8%.
Precision (Total CV)	Not explicitly stated as acceptance criteria.	In testing three HDL levels for 23 days, the total CV ranged from 6.0% to 6.5%. In precision studies at three separate POL sites and in-house over five days, the total CV ranged from 1.2% to 3.4%.
Accuracy (Correlation Coefficient)	Not explicitly stated, but high correlation (close to 1) with comparative method is expected.	0.970 (in-house study) and 0.9696 to 0.9957 (POL sites) using least-squares regression analysis against a comparative method.
Accuracy (Confidence Interval Slope)	Not explicitly stated, but expected to be close to 1.	0.923 to 1.022 (in-house study) and 0.879 to 1.020 (POL sites).
Accuracy (Confidence Interval Intercept)	Not explicitly stated, but expected to be close to 0.	-0.5 to 5.2 (in-house study) and -0.7 to 9.0 (POL sites).
Accuracy (Standard Error Estimate)	Not explicitly stated, but low values are preferred.	4.8 (in-house study) and 1.7 to 4.7 (POL sites).
Detection Limit	Not explicitly stated, but a low value is preferred.	6 mg/dL.
Serum vs. Plasma Difference	Not statistically significant difference between means (paired t-test, α = 0.05).	Paired t-test for means resulted in a t-Statistic of 0.40, which was not statistically significant at α = 0.05 (t-Critical value 2.03). Range: 14 to 124 mg/dL (serum).
S-Test TG		-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Precision (Within-run CV)	Not explicitly stated as acceptance criteria.	In testing three TG levels for 22 days, the within-run CV ranged from 3.3% to 4.1%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 0.5% to 3.9%.
Precision (Total CV)	Not explicitly stated as acceptance criteria.	In testing three TG levels for 22 days, the total CV ranged from 3.8% to 4.3%. In precision studies at three separate POL sites and in-house over five days, the total CV ranged from 0.6% to 3.9%.
Accuracy (Correlation Coefficient)	Not explicitly stated, but high correlation (close to 1) with comparative method is expected.	0.997 (in-house study) and 0.9958 to 0.9990 (POL sites) using least-squares regression analysis against a comparative method.
Accuracy (Confidence Interval Slope)	Not explicitly stated, but expected to be close to 1.	1.049 to 1.088 (in-house study) and 0.940 to 1.084 (POL sites).
Accuracy (Confidence Interval Intercept)	Not explicitly stated, but expected to be close to 0.	-21.2 to -13.7 (in-house study) and -19.0 to 2.9 (POL sites).
Accuracy (Standard Error Estimate)	Not explicitly stated, but low values are preferred.	8.7 (in-house study) and 6.6 to 11.9 (POL sites).
Detection Limit	Not explicitly stated, but a low value is preferred.	12 mg/dL.
Serum vs. Plasma Difference	Not statistically significant difference between means (paired t-test, α = 0.05).	Paired t-test for means resulted in a t-Statistic of 2.04, which was not statistically significant at α = 0.05 (t-Critical value 2.05). Range: 36 to 572 mg/dL (serum).

Study Proving Device Meets Acceptance Criteria:

The studies described are primarily analytical performance studies conducted by Alfa Wassermann Diagnostics Technologies, LLC, both in-house and at Physician Office Laboratory (POL) sites. These studies evaluated precision, accuracy, detection limits, and matrix comparisons (serum vs. plasma).

Additional Information on the Study:

Sample sizes used for the test set and the data provenance:
- S-Test CHO:
  - Accuracy (correlation study): 98 samples (range: 31 to 335 mg/dL).
  - Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
  - Serum vs. Plasma: 29 paired samples.
- S-Test HDL:
  - Accuracy (correlation study): 94 samples (range: 15 to 116 mg/dL).
  - Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
  - Serum vs. Plasma: 36 paired samples.
- S-Test TG:
  - Accuracy (correlation study): 87 samples (range: 24 to 584 mg/dL).
  - Accuracy (POL sites): Sample sizes not explicitly stated, but refers to "patient correlation studies."
  - Serum vs. Plasma: 30 paired samples.
- Data Provenance: The studies were conducted by the manufacturer, Alfa Wassermann Diagnostic Technologies, LLC, both in-house ('in-house over five days') and at three separate Physician Office Laboratory (POL) sites. The text does not specify the country of origin of the data, but the 510(k) owner is based in West Caldwell, NJ, USA. The data appears to be prospective in nature, as indicated by controlled experiments like "testing three CHO levels for 22 days."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is an analytical performance study for an in vitro diagnostic (IVD) device, not an interpretative imaging or diagnostic test requiring human expert adjudication for ground truth.
- The "ground truth" or reference method for accuracy studies was a "comparative method (x)." The specific identity or nature of this comparative method is not detailed, but for IVDs, this typically refers to a well-established, often FDA-cleared, reference assay run on another analyzer or a gold standard method. No human experts are described as establishing ground truth in this context.
Adjudication method for the test set:
- Not applicable. This is an analytical performance study comparing the device's quantitative measurements against a comparative method. There is no human adjudication process involved as would be seen in image interpretation or clinical diagnosis studies.
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:
- Not applicable. This is an analytical performance study of an in vitro diagnostic (IVD) assay, not an AI-assisted diagnostic imaging or interpretative tool. There are no human readers or AI involved in the interpretation of results in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, the performance data presented are for the standalone analytical performance of the S-Test reagent cartridges on the S40 Clinical Analyzer. This represents the "algorithm only" or device-only performance for quantitative measurements of cholesterol, HDL, and triglycerides. There is no mention of a human-in-the-loop component in the direct measurement process.
The type of ground truth used:
- The "ground truth" for the accuracy studies was established by a "comparative method (x)." This means the new device's measurements were compared against another existing, presumably validated, method for measuring cholesterol, HDL, and triglycerides. This is a common practice for demonstrating analytical accuracy for IVD devices, comparing to a "reference standard" or "predicate device" method.
The sample size for the training set:
- Not applicable. This is an analytical performance study of a reagent system, not a machine learning or AI model that requires a training set. The device's performance is characterized through experiments.
How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned in the context of this analytical performance study.

Summary

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		510(k) SUMMARY
510(k) Owner:	Alfa Wassermann Diagnostic Technologies, LLC4 Henderson DriveWest Caldwell, NJ 07006
	Contact:	Hyman Katz, Ph.D.Phone: 973-852-0158Fax: 973-852-0237
Date SummaryPrepared:	May 12, 2009		(updated October 19, 2009)
Device:	Trade Name:	S-Test CHO, S-Test HDL, and S-Test TG Reagent cartridges
	Classification:	Class I
	Common/Classification Names:		Enzymatic esterase-oxidase,cholesterol (21 C.F.R. §862.1475)Product Code CHH
		Lipoprotein test system (HDL)(21 C.F.R. § 862.1475)Product Code LBS
		Lipase hydrolysis/glycerol kinaseenzyme triglycerides test system(21 C.F.R. § 862.1705)Product Code CDT
PredicateDevices:	Manufacturer for analyzer/reagent system predicate:
	Alfa Wassermann ACE plus ISE/Clinical Chemistry SystemCholesterol, HDL Cholesterol and Triglycerides Reagents (K931786)
DeviceDescription:	The S-Test Cholesterol (CHO), S-Test HDL Cholesterol (HDL) and S-Test Triglycerides (TG) reagent cartridges, used with the S40 ClinicalAnalyzer, are intended for quantitative in vitro diagnostic determinationof CHO, HDL, and TG concentrations in serum or heparin plasmabased on a photometric test measuring the formation of reddish purplecomplexes in coupled enzymatic reactions.

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Intended Use:	The S-Test Cholesterol Reagent is intended for the quantitativedetermination of cholesterol concentration in serum or heparin plasmausing the S40 Clinical Analyzer. Cholesterol measurements are used inthe diagnosis and treatment of disorders involving excess cholesterolin the blood and lipid and lipoprotein metabolism disorders. This testis intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only.
	The S-Test High Density Lipoprotein Reagent is intended for thequantitative determination of HDL concentration in serum or heparinplasma using the S40 Clinical Analyzer. Lipoprotein measurementsare used in the diagnosis and treatment of lipid disorders (such asdiabetes mellitus), atherosclerosis, and various liver and renal diseases.This test is intended for use in clinical laboratories or physician officelaboratories. For in vitro diagnostic use only.
	The S-Test Triglycerides Reagent is intended for the quantitativedetermination of triglyceride concentration in serum or heparin plasmausing the S40 Clinical Analyzer. Triglyceride measurements are usedin the diagnosis and treatment of patients with diabetes mellitus,nephrosis, liver obstruction, other diseases involving lipid metabolism,or various endocrine disorders. This test is intended for use in clinicallaboratories or physician office laboratories. For in vitro diagnostic useonly.
TechnologicalCharacteristics:	The S-Test CHO Reagent is contained in a bi-reagent cartridge.Reagent 1 contains 4-aminoantipyrine, cholesterol esterase, andperoxidase. Reagent 2 contains cholesterol oxidase and N-ethyl-N-sulfobutyl-m-toluidine.
	The S-Test HDL Reagent is contained in a bi-reagent cartridge.Reagent 1 contains N,N-bis(4-sulfobutyl)-m-toluidine, cholesteroloxidase, peroxidase, and bis (2-hydroxyethyl) iminotris (hydroxymethyl)methane. Reagent 2 contains 4-aminoantipyrine, a surface-active agent,cholesterol esterase, and bis (2-hydroxyethyl) iminotris (hydroxymethyl)methane.
	The S-Test TG Reagent is contained in a bi-reagent cartridge. Reagent1 contains Glycerol kinase, glycerol-3-phosphate oxidase, N-ethyl-N-sulfobutyl-m-toluidine, and piperazine-N,N'-bis(2-ethanesulfonic acid).Reagent 2 contains 4-aminoantipyrine, lipoprotein lipase, peroxidase,piperazine-N,N'-bis(2-ethanesulfonic acid).
PerformanceData:	S-Test CHOPerformance data on the S-Test CHO included precision, accuracy, detection limit, and matrix comparison data.Precision: In testing three CHO levels for 22 days, the within-run CV ranged from 0.9% to 1.6%, and total CV ranged from 2.2% to 2.6%. In precision studies at three separate Physician Office Laboratory (POL) sites and in-house over five days, the within-run CV ranged from 0.3% to 2.0% and total CV ranged from 0.7% to 2.0%.Accuracy: In a correlation study, 98 samples with CHO values ranging from 31 to 335 mg/dL were assayed on the S40 Clinical Analyzer using S-Test CHO (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.983, a standard error estimate of 11.3, a confidence interval slope of 0.942 to 1.014, and a confidence interval intercept of -3.8 to 10.8. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 0.9585 to 0.9969, standard error estimates of 4.8 to 16.7, confidence interval slopes of 0.868 to 1.056, and a confidence interval intercepts of -15.7 to 16.2.Detection Limit: The detection limit was 7 mg/dL.Serum vs. Plasma: A study was performed by running CHO determinations on 29 paired samples drawn from the same patients in serum and heparin plasma tubes. The use of plasma was confirmed in a matrix comparison study. The means for serum (149 mg/dL) and plasma (147 mg/dL) differed by less than the tolerance limit of ±5%. The range in serum was 22 to 249 mg/dL.
	S-Test HDLPerformance data on the S-Test HDL included precision, accuracy, detection limit, and matrix comparison data.Precision: In testing conducted at three HDL levels for 23 days, the within-run CV ranged from 2.0% to 2.8%, and total CV ranged from 6.0% to 6.5%. In precision studies at three separate POL sites and in-house over five days, the within-run CV ranged from 1.2% to 2.8% and total CV ranged from 1.2% to 3.4%.Accuracy: In the correlation study, 94 samples with HDL values ranging from 15 to 116 mg/dL were assayed on the S40 Clinical Analyzer using S-Test HDL (y) and a comparative method (x). Least-squares regression analysis yielded a correlation coefficient of 0.970, a standard error estimate of 4.8, a confidence interval slope of 0.923 to 1.022, and a confidence interval intercept of -0.5 to 5.2. In patient correlation studies at three separate POL sites using the S40 Clinical

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Analyzer and a comparative method, least-squares regression analysis yielded correlation coefficients of 0.9696 to 0.9957 standard error estimates of 1.7 to 4.7, confidence interval slopes of 0.879 to 1.020, and a confidence interval intercepts of -0.7 to 9.0.

Detection Limit: The detection limit was 6 mg/dL.

Serum vs. Plasma: A study was performed by running HDL determinations on 36 paired samples drawn from the same patients in serum and heparin plasma tubes. The use of plasma was confirmed in a matrix comparison study using the paired t-test for means: Range: 14 to 124 mg/dL (serum), t-Statistic = 0.40, t-Critical value 2.03 at a = 0.05, not statistically significant.

S-Test TG

Performance data on the S-Test TG included precision, accuracy, detection limit, and matrix comparison data.

Precision: In testing conducted at three TG levels for 22 days, the within-run CV ranged from 3.3% to 4.1%, and total CV ranged from 3.8% to 4.3%. In precision studies at three separate POL sites and inhouse over five days, the within-run CV ranged from 0.5% to 3.9% and total CV ranged from 0.6% to 3.9%.

Accuracy: In the correlation study, 87 samples with TG values ranging from 24 to 584 mg/dL were assayed on the S40 Clinical Analyzer using S-Test TG (y) and a comparative method (x). Least-squares regression analysis vielded a correlation coefficient of 0.997, a standard error estimate of 8.7, a confidence interval slope of 1.049 to 1.088, and a confidence interval intercept of -21.2 to -13.7. In patient correlation studies at three separate POL sites using the S40 Clinical Analyzer and a comparative method. least-squares regression analysis vielded correlation coefficients of 0.9958 to 0.9990, standard error estimates of 6.6 to 11.9, confidence interval slopes of 0.940 to 1.084, and a confidence interval intercepts of -19.0 to 2.9.

Detection Limit: The detection limit was 12 mg/dL.

Serum vs. Plasma: A study was performed by running TG determinations on 30 paired samples drawn from the same patients in serum and heparin plasma tubes. The use of plasma was confirmed in a matrix comparison study using the paired t-test for means: Range: 36 to 572 mg/dL (serum), t-Statistic = 2.04. t-Critical value 2.05 at a = 0.05, not statistically significant.

Based on the foregoing data, the devices are safe and effective. These Conclusions: data also indicate substantial equivalence to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Alfa Wassermann, Inc. c/o Hyman Katz, PhD Vice President, Quality and Regulatory Affairs 4 Henderson Drive OCT 2 6 2009 West Caldwell, NJ 07006

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Re: K091413

Trade Name: S-Test Cholesterol (CHO), S-Test High Density Lipoprotein Cholesterol (HDL), S-Test Triglycerides (TG) Regulation Number: 21 CFR $862.1175 Regulation Name: Cholesterol (total) test system. Regulatory Class: Class I. meets limitation of exemption 862.9 (c)(4) and (c)(9) Product Codes: CHH, LBS, CDT Dated: October 19, 2009 Received: October 21, 2009

Dear Dr. Katz:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Courtney C. Harper, Ph.D. 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): K091413

Device Name: S-Test Cholesterol (CHO)

Indication For Use: The S-Test Cholesterol Reagent is intended for the quantitative determination of cholesterol concentration in serum or heparin plasma using the S40 Clinical Analyzer. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. 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)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091413

Page 1 of 3

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Indication for Use

510(k) Number (if known): K091413

Device Name: S-Test High Density Lipoprotein Cholesterol (HDL)

Indication For Use:

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)

Carl Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091413

Page 2 of 3

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Indication for Use

510(k) Number (if known): K091413

Device Name: S-Test Triglycerides (TG)

Indication For Use:

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 (OIVD)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

.510(k) K091413

Page 3 of 3

Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.