The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole blood. The APOLOWAKO TG is for the quantitative determination on the APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.

APOLOWAKO Analyzer is a discrete photometric chemistry analyzer for clinical use in both central laboratories and in point of care sites. The device is intended to duplicate manual analytical procedures by automatically performing various steps such as pipetting, mixing and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes of clinical interest in whole blood samples.

The measurements of total cholesterol, HDL cholesterol, triglycerides, and LDL cholesterol (by calculation for triglyceride values up to 400 mg/dL) when used in conjunction with other biochemical markers and coronary risk factors, is useful in the prediction of CHD/CVD risk and the assessment of CHD/CVD severity.

Device Description

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. The analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two enzyme color reagents and a lyophilized calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results are shown. The APOLOWAKO's lipid panel will include, total cholesterol, HDL cholesterol, LDL cholesterol (by calculation), and triglycerides in tubed venous whole blood. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

AI/ML Overview

The provided text describes the Wako Diagnostics APOLOWAKO Lipid Panel and Analyzer, a point-of-care test system designed for the quantitative determination of total cholesterol, HDL cholesterol, and triglycerides in whole blood, with calculated LDL cholesterol. The device aims for substantial equivalence to the CHOLESTECH LDX system.

Here's an analysis of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a separate section. Instead, the performance characteristics (imprecision, linearity, interference) of the APOLOWAKO system are compared against or shown to be superior to those of the predicate device (Cholestech LDX) and demonstrate acceptable analytical performance. The substantial equivalence conclusion is based on comparable or better performance characteristics.

Performance Characteristic	Acceptance Criteria (Implicit, based on Predicate or generally acceptable analytical performance)	Reported Device Performance (APOLOWAKO Lipid Panel)
Triglycerides
Within-day Imprecision	%CV comparable to or better than predicate (Pred: < 3.2% CV)	0.5% CV to 2.9% CV
Between-day Imprecision	%CV comparable to or better than predicate	0.9% CV to 1.8% CV
Linearity	Linear throughout reportable range	Linear throughout reportable range
Interference	No interference from common interferents	No interference from hemoglobin, bilirubin, free glycerol.
Total Cholesterol
Within-day Imprecision	%CV comparable to or better than predicate (Pred: < 4.0% CV)	0.5% CV to 1.2% CV
Between-day Imprecision	%CV comparable to or better than predicate	0.6% CV to 1.7% CV
Linearity	Linear throughout reportable range	Linear throughout reportable range
Interference	No interference from common interferents	No interference from hemoglobin, bilirubin, triglycerides, ascorbic acid, EDAT-2Na, heparin sodium.
HDL-C
Within-day Imprecision	%CV comparable to or better than predicate (Pred: < 6.5% CV)	0.5% CV to 1.6% CV
Between-day Imprecision	%CV comparable to or better than predicate	0.5% CV to 1.6% CV
Linearity	Linear throughout reportable range	Linear throughout reportable range
Interference	No interference from common interferents	No interference from hemoglobin, bilirubin, triglycerides, ascorbic acid, EDAT-2Na, heparin sodium.
Method Comparison	Clinically significant correlation with reference methods (slopes approaching 1.0, y-intercepts approaching zero, correlation coefficient ≥ 0.945)	Correlation coefficients of 0.945 or better for each assay (with reference methods). Slopes approaching 1.0 and y-intercepts approaching zero.

2. Sample size used for the test set and the data provenance:

Sample Size (Clinical Data/Method Comparison): 388 samples for Total Cholesterol and Triglycerides. 384 samples for HDL-cholesterol (4 samples out of detectable range).
Data Provenance: Not explicitly stated, but the study refers to "rigorous conditions sufficient to meet the requirements for CLIA Waiver," which implies a clinical setting. No specific country of origin is mentioned. The study appears to be prospective as it's for premarket notification of a new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable. The ground truth for the method comparison study was established by FDA-cleared comparison (reference) methods, not by expert consensus on image interpretation or similar qualitative assessments.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable. The evaluation relies on quantitative measurements against reference methods, not subjective adjudication of results.

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:

MRMC Study: No. This is a diagnostic device for quantitative chemical analysis, not an imaging or qualitative assessment device that would typically involve human readers or AI assistance in interpretation in the context of an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: Yes, the device's performance as a standalone analytical instrument is demonstrated through the non-clinical (imprecision, linearity, interference) and clinical (method comparison) studies. It performs the measurements and calculations independently.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground Truth: For the clinical data (method comparison study), the ground truth was established by FDA-cleared comparison methods (reference methods) for total cholesterol, triglycerides, and HDL-cholesterol.

8. The sample size for the training set:

Training Set Sample Size: Not explicitly mentioned. For this type of chemical analyzer, the "training" (calibration and initial validation of reagents) is inherent in the design and manufacturing process, and performance is demonstrated through studies on defined analytical controls and clinical samples. It's not a machine learning model with a distinct "training set" in the traditional sense. Calibration is performed when the reagent is opened.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: The document mentions "lyophilized calibrator" included in each reagent unit. This calibrator, traceable to recognized standards, would establish the ground truth for the calibration process and ensure accurate measurement by the device. The methodology is enzyme-based colorimetric, requiring calibration against known concentrations.

Summary

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KOS012>

Wako Wako Diagnostics

JUL 1 8 2008

SECTION 9

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is K080125.

Wako Diagnostics 807.92 (a)(1): Name:

Address: 665 Clyde Avenue, Suite B Mountain Vicw, CA 94043 Phone: (650) 210-9153 FAX: (650) 210-9170 Contact: Peter Panfili, Ph.D.

807.92 (a)(2): Device name- trade name and common name, and classification

Trade Name:

APOLOWAKO Lipid Panel*, composed of; APOLOWAKO T-CHO APOLOWAKO HDL-C APOLOWAKO TG APOLOWAKO Analyzer and accessories

APOLOWAKO Lipid Panel is a generic name for the above three reagents for lipids determination in whole

Common Name:

Test system for individual reporting of:

total cholesterol
HDL cholesterol -
triglyccrides -
LDL cholesterol (by Friedewald calculation) -
-Discrete photometric chemistry analyzer for clinical use

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Classification:

Total cholesterol: §21.862.1175 HDL cholesterol: §21.862.1475 Triglycerides: $21.862.1705 LDL cholesterol: §21.862.1475 (by calculation) Discrete photometric chemistry analyzer for clinical use: 821.862.2160

807.92 (a)(3): Identification of the legally marketed predicate device

CHOLESTECH LDX, Cholestech Corporation, Hayward, CA cleared under K954778 and K946067 for lipids.

807.92 (a)(4): Device Description

807.92 (a)(5): Intended Use

The APOLOWAKO Lipid Panel is for the quantitative determination of total cholesterol. HDL cholesterol and triglycerides in whole blood and also calculates and gives results for LDL cholesterol and the T-CHO/HDL-C ratio.

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Image /page/2/Picture/0 description: The image shows the logo for Wako Diagnostics. The word "Wako" is written in white on a black rectangle on the left side of the image. To the right of the rectangle, the words "Wako Diagnostics" are written in black.

807.92 (a)(6): Technological Similarities and Differences to the Predicate

Predicate Device (Cholestech LDX)
CHARACTERISTIC	APOLOWAKO Analyzer	Cholestech LDX System
Intended Use	The APOLOWAKO LipidPanel is used for the in vitroquantitative determination oftotal cholesterol, HDLcholesterol, LDL cholesterol(by calculation), triglyceridesin whole blood and the T-CHO/HDL-C ratio.	The Cholestech LDX Systemis used for the quantitativedetermination of totalcholesterol, HDL (high-density lipoprotein)cholesterol and triglyceridesglucose in whole blood. ATC/HDL (totalcholesterol/HDL cholesterolratio and estimated values forLDL (low densitylipoprotein) and non-HDLcholesterol are calculated bythe Cholestech LDX.
Indications for Use	The measurement of totalcholesterol, HDL cholesterol,LDL cholesterol, andtriglycerides when used inconjunction with otherbiochemical markers andcoronary risk factors, isuseful in the prediction ofCHD/CVD risk and theassessment of CHD/CVDseverity.	Lipoprotein measurementsare used in the diagnosis andtreatment of lipid disorderssuch as diabetes mellitus,atherosclerosis, and variousliver and renal diseases.
Sample	Whole blood	Whole blood
Sample Preparation	Venous whole blood sample	Finger stick or venous wholeblood sample
Calibration	Calibration is required at thetime the reagent is openedand lasts for 28 days or untilexpiration date.	No calibration is performedby the user.
Methodology	Colorimetric, enzyme-based	Colorimetric
Reagent Format	Liquid	Dry
Testing Environment	Professional use, point-of-care	Professional use, point-of-care

Reportablerange	T-CHO: 25-330 mg/dLHDL-C: 8.0-100 mg/dLTG: 30-625 mg/dLLDL-C by calculation	T-CHO: 100 to 500 mg/dLHDL-C: 15-100 mg/dLTG: 45-650 mg/dLLDL-C by calculation
Precision	T-CHO: Total imprecision less than 2.0% CV across a range of 133 mg/dL to 788 mg/dL (mean values)HDL-C: Total imprecision less than 2.0% CV across a range of 38.8 mg/dL to 100.3 mg/dL (mean values)TG: Total imprecision less than 2.0% across a range of 90 mg/dL to 1178 mg/dL (mean values)	T-CHO: Total imprecision less than 4.0% across a range of 161 mg/dL to 244 mg/dL (mean values)HDL-C: Total imprecision less than 6.5% CV across a range of 29 mg/dL to 46 mg/dL (mean values)TG: Total imprecision less than 3.2% across a range of 121 mg/dL to 276 mg/dL (mean values)
Linearity	Assay linear throughout reportable range	Assay linear throughout reportable range
InterferingSubstances	No interference from high levels of bilirubin (conjugated and unconjugated), hemoglobin, EDTA-2Na, heparin sodium and ascorbic acid.No interference from triglycerides on T-CHO and HDL-C measurements.	There are 23 substances including hemoglobin, bilirubin and uric acid that did not interfere with the assay. Free glycerol does affect Cholestech TG test but it does not affect APOLOWAKO TG.

Similarities / Differences between the APOLOWAKO Lipid Panel and Established Predicate Device (Cholestech LDX)

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807.92 (b)(1): Brief Description of Non-clinical Data

Evaluations were performed for within-day imprecision, between-day imprecision, linearity, and interfering substances. Those resulting data are summarized below.

Triglyceride

Within-day imprecision, when evaluated at three levels of triglyceride (low- 45 mg/dL, intermediate- 139 mg/dL, and high- 1209 mg/dL), ranged from 0.5 % CV to 2.9 % CV. Between-day imprecision, when evaluated in duplicate over 10 days, ranged 0.9 % CV to 1.8 % CV.

Results from linearity studies demonstrated that the triglyceride is linear throughout the reportable range.

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Wako Diagnostics Wako

Results from an interference testing showed triglyceride assay is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated) or free glycerol.

Total Cholestcrol

Within-day imprecision, when evaluated at three levels of total cholesterol (low- 122 mg/dL, intermediate- 187 mg/dL, and high- 764 mg/dL), ranged from 0.5 % CV to 1.2 % CV. Between-day imprecision, when evaluated in duplicate over 10 days, ranged 0.6 % CV to 1.7 % CV.

Results from linearity studies demonstrated that the total cholesterol is linear throughout the reportable range.

Results from an interference testing showed that the total cholesterol is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, or heparin sodium.

HDL-C

Within-day imprecision, when cvaluated at three levels of HDL-C (low-30.8 mg/dL, intermediate- 51.1 mg/dL, and high- 95.2 mg/dL), ranged from 0.5 % CV to 1.6 % CV. Between assay imprecision, when evaluated in duplicate over 10 days, ranged 0.5 % CV to 1.6 % CV.

Results from linearity studies demonstrated that the HDL-C assay is linear throughout the reportable range.

Results from an interference testing showed that the HDL-C is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, or heparin sodium.

807.92 (b)(2): Brief Description of Clinical Data

The method comparison study shows substantial equivalence to FDA cleared comparison methods for total cholesterol, triglycerides and HDLcholesterol. For each analyte. 388 (384 for HDL-cholesterol; 4 samples out of the detectable range) broadly distributed samples showed statistically significant correlation with the reference method with slopes approaching 1.0 and y-intercepts approaching zero. APOLOWAKO results were collected under rigorous conditions sufficient to meet the requirements for CLIA Waiver. The results show correlation coefficients of 0.945 or better for each assay.

807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 1 8 2008

Wako Chemicals USA, Inc. c/o Peter Panfili, Ph.D. 665 Clyde Avenue, Suite B Mountain View, CA 94043

K080125 Re:

Trade/Device Name: APOLOWAKO T-CHO, APOLOWAKO HDL-C, APOLOWAKO TG and APOLOWAKO Analyzer and accessories Regulation Number: 21 CFR 862.1175 Regulation Name: Cholesterol (total) test system Regulatory Class: Class I Product Code: CGO, CDT, LBS and JJE Dated: June 24, 2008 Received: June 30, 2008

Dear Dr. Panfili:

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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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/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean 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): K080125

Device Name:

APOLOWAKO T-CHO APOLOWAKO HDL-C APOLOWAKO TG APOLOWAKO Analyzer and accessories

Intended Use

The APOLOWAKO T-CHO is for the quantitative determination on the APOLOWAKO analyzer of total cholesterol in whole blood. The APOLOWAKO HDL-C is for the quantitative determination on the APOLOWAKO analyzer of HDL cholesterol in whole The APOLOWAKO TG is for the quantitative determination on the blood. APOLOWAKO analyzer of triglycerides in whole blood. In conjunction with the above values, the APOLOWAKO analyzer also calculates LDL cholesterol for triglyceride values up to 400 mg/dL and T-CHO/HDL-C ratio.

Indications for Use

Prescription Use(21 CFR Part 801 Subpart D)	X	And/Or	Over the Counter Use(21 CFR Part 801 Subpart C)
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(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) K080125

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.