System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers. Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various enocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

Device Description

This Olympus Triglyceride procedure is based on a series of coupled enzymatic reactions. The triglycerides in the sample are hydrolyzed by a combination of microbial lipases to give glycerol and fatty acids. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate. The glycerol-3-phosphate is oxidized by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. The formed H2O2 reacts with 4-aminophenazone and N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore, which is read at 660/800nm. The increase in absorbance at 660/800 nm is proportional to the triglyceride content of the sample.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Olympus Triglyceride Test System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparison to a predicate device, showing "similarities" and specific performance characteristics. The specific thresholds for acceptable performance are not explicitly stated as strict "acceptance criteria" but rather as "Performance Characteristics" which are compared to the predicate device.

Performance Characteristic	Acceptance Criteria (Implied by Predicate)	New Olympus Triglyceride Reported Performance	Predicate Reported Performance
Precision AU400/400e	Comparable to predicate	Sample 1: 2.58% CV	Sample 1: 1.21% CV
		Sample 2: 2.54% CV	Sample 2: 1.67% CV
		Sample 3: 2.41% CV	Sample 3: 1.37% CV
Precision AU600/640/640e	Comparable to predicate	AU600:	AU600:
		Sample 1: 1.65% CV	Sample 1: 1.83% CV
		Sample 2: 1.41% CV	Sample 2: 1.58% CV
		Sample 3: 1.46% CV	Sample 3: 2.80% CV
			Sample 4: 1.13% CV
		AU640/640e:	AU640/640e:
			Sample 1: 1.00% CV
			Sample 2: 1.00% CV
Precision AU2700/5400	Comparable to predicate	Sample 1: 2.00% CV	Sample 1: 2.50% CV
		Sample 2: 1.72% CV	Sample 2: 2.00% CV
		Sample 3: 1.78% CV	Sample 3: 1.50% CV
			Sample 4: 1.20% CV
Assay Range	10 - 1000 mg/dL	10 - 1000 mg/dL	10 - 1000 mg/dL
Method Comparison	Slope ≈ 1, Intercept ≈ 0, R ≈ 1	Intercept: -0.871	Intercept: 3.2
		Slope: 1.011	Slope: 1.010
		R: 1.000	R: 0.999
Interfering Substances	Performance generally comparable to predicate, with limits on interference	AU400/400e/600/640/640e/2700/5400:	AU400/400e:
Ascorbate	≤ 2-10%	≤ 5% up to 20 mg/dL	≤ 2% up to 20mg/dL
Bilirubin	≤ 10%	≤ 3% up to 40 mg/dL	≤ 10% up to 20 mg/dL
Hemolysis	≤ 7-8%	≤ 3% up to 500 mg/dL	≤ 8% up to 500 mg/dL
			AU600/640/640e:
Ascorbate			≤ 1% up to 20mg/dL
Bilirubin			≤ 10% up to 32 mg/dL
Hemolysis			≤ 7% up to 500 mg/dL
			AU2700/5400:
Ascorbate			≤ 2% up to 20mg/dL
Bilirubin			≤ 10% up to 16 mg/dL
Hemolysis			≤ 8% up to 500 mg/dL

Study Details:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "samples" for precision and method comparison studies but does not specify the exact number of samples (sample size) used for the test sets. For precision, multiple "samples" (likely control or pooled patient samples) were tested across different Olympus analyzer models. For method comparison, it implies a set of samples were run on both the new and predicate devices, yielding the Intercept, Slope, and R values.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This is a diagnostic reagent for quantitative measurement of triglyceride concentrations, not an imaging device requiring expert interpretation. Therefore, the concept of "experts establishing ground truth" in the interpretive sense does not directly apply. The "ground truth" for such devices is established through reference methods or highly characterized control materials. The document states traceability to College of American Pathology (CAP) Serum Lipid (RM016) #2, which serves as the reference for accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is a quantitative chemical assay, not an interpretive device 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
- Not applicable. This is a chemical diagnostic reagent device, not an AI or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance data presented (precision, assay range, method comparison, interfering substances) represents the standalone performance of the Olympus Triglyceride Reagent when run on Olympus analyzers. There is no human-in-the-loop component for the direct measurement of triglycerides by this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for accuracy and calibration is based on traceability to College of American Pathology (CAP) Serum Lipid (RM016) #2. This implies that the device's measurements are referenced against established standards or values obtained from a highly reliable and recognized reference material.
8. The sample size for the training set
- Not applicable. This is a chemical reagent, not a machine learning or AI device that typically requires a "training set." The development would involve chemical optimization and formulation, followed by validation studies.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of device. The development and validation relied on established chemical principles and reference materials (like CAP standards).

Summary

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Triglyceride 510(k)

Ko63804

Section 2 - 510(k) Summary

As required by 21 CFR 807.87 (h) -

MAR 2 3 2007

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

...

1. Submitter name, address, contact	Olympus America3131 W Royal LaneIrving, TX 75063
Telephone:	972-619-4710
Fax:	972-556-0365
Contact Person:	Bev Harding
Date Prepared:	December 18, 2006
2. Device name
Proprietary Name:	Olympus Triglyceride Reagent
Common Name:	Triglyceride Reagent
Classification Name:	Triglyceride Test System,
3. Predicate device
Reagent:	Olympus Triglyceride OSR6x33 (K961274)
4. Device description	This Olympus Triglyceride procedure is based on a series of coupled enzymatic reactions. The triglycerides in the sample are hydrolyzed by a combination of microbial lipases to give glycerol and fatty acids. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate. The glycerol-3-phosphate is oxidized by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. The formed H2O2 reacts with 4-aminophenazone and N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore, which is read at 660/800nm. The increase in absorbance at 660/800 nm is proportional to the triglyceride content of the sample.

Triglycerides + 3 H2O Lipase → Glycerol + 3 Fatty Acids

Glycerol + ATP GK,Mg2+→ Glycerol-3-phosphate + ADP

Glycerol-3-phosphate + O2 GPO→ H2O2 + Dihydroxyacetone phosphate

2 H2O2 + MADB + 4AAP Peroxidase → Blue Dye + OH + H2O

5. Intended use	System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers.
-----------------	----------------------------------------------------------------------------------------------------------------------------------

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Triglyceride 510(k)

Section 2 - 510(k) Summary

მ. The following Tables compare the new Olympus Triglyceride OSR6x118 with the Olympus Triglyceride OSR6x33

Similarities
Item	New Olympus Triglyceride	Predicate
Measurement	Quantitative	Same
Chemical reaction	Enzymatic GPO methodology with Trinderindicator system	Same
Sample dilution	Not required	Same
Reagent Materials	Lipoprotein Lipase and coupling enzymesand co-factors	Same
Traceability	College of American Pathology (CAP)Serum Lipid (RM016) # 2	Same
Reagent storage form	Liquid ready to use	Same
Reagent On BoardStability	30 days on board	Same
Calibration	Single Point	Same
Calibration Stability	30 days	Same
Quality Controls	2 Levels	Same

Item	New Olympus Triglyceride	Predicate
Intended Use	System reagent for the quantitative determination ofTriglyceride concentrations in human serum and plasma onOLYMPUS analyzers	System reagent for thequantitativedetermination ofTriglycerideconcentrations inhuman serum onOLYMPUS analyzers
Catalogue Number	OSR6x118	OSR6x33
Specimen Type	Serum and Plasma	Serum
Indicator	N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt(MADB)	4-chlorophenol
Methodology	Enzymatic endpoint at approximately 660nm	Enzymatic endpoint atapproximately 520nm
Expected Values	Adults: 48 - 352mg/dLTriglyceride<150 mg/dL150-199 mg/dL200-499 mg/dL≥500 mg/dL	Adults: 48 -352mg/dL
	Risk ClassificationNormalBorderline HighHighVery High

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Triglyceride 510(k)

Section 2 - 510(k) Summary

Performance Characteristics
Item	New Olympus Triglyceride	Predicate
Precision AU400/400e	Sample	Total CV%	Sample	Total CV%
	1	2.58	1	1.21
	2	2.54	2	1.67
	3	2.41	3	1.37
PrecisionAU600/640/640e	Sample	Total CV%	AU600Sample	Total CV%
	1	1.65	1	1.83
	2	1.41	2	1.58
	3	1.46	3	2.80
			4	1.13
			AU640/640eSample	Total CV%
			1	1.00
			2	1.00
Precision AU2700/5400	Sample	Total CV%	Sample	Total CV%
	1	2.00	1	2.50
	2	1.72	2	2.00
	3	1.78	3	1.50
			4	1.20
Assay Range	10 - 1000 mg/dL		10 - 1000 mg/dL
	Intercept	-0.871	Intercept	3.2
Method Comparison	Slope	1.011	Slope	1.010
	R	1.000	R	0.999
Interfering Substances	AU400/400e/600/640/640e/2700/5400Ascorbate ≤ 5% up to 20 mg/dLBilirubin ≤ 3% up to 40 mg/dLHemolysis ≤ 3% up to 500 mg/dL		AU400/400eAscorbate ≤ 2% up to 20mg/dLBilirubin ≤ 10% up to 20 mg/dLHemolysis ≤ 8% up to 500 mg/dL
			AU600/640/640eAscorbate ≤ 1% up to 20mg/dLBilirubin ≤ 10% up to 32 mg/dLHemolysis ≤ 7% up to 500 mg/dL
			AU2700/5400Ascorbate ≤ 2% up to 20mg/dLBilirubin ≤ 10% up to 16 mg/dLHemolysis ≤ 8% up to 500 mg/dL

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Olympus America, Inc. c/o Ms. Bev Harding 3131 West Royal Lane Irving, TX 75063-3104

MAR 2 3 2007

K063804 Re:

Trade/Device Name: Olympus Triglyceride Test System Regulation Number: 21 CFR8 862.1705 Regulation Name: Triglyceride test system. Regulatory Class: Class I meets limitations of exemptions, 21 CFR 862.9 (c) (4) Product Code: CDT Dated: March 16, 2007 Received: March 19, 2007

Dear Ms. Harding:

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. Ilsting 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 10gally marketed predicate device results in a classification for your device and thus, serroot to 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 othe 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 tolloft the (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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510(k) Number (if known): K063804

Device Name:

Olympus Triglyceride Test System.

Indications for Use:

System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers

Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various enocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

Prescription Use (Part 21 CFR 801.Subpart D)

Over-The-Counter Use (Part 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 Diagnostics Devices (OIVD)

Division Sign-Off

ice of In Vitro Diagnostic Device ation and Safe

Regulation Number and Section

§ 862.1705 Triglyceride test system.

(a)
Identification. A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine 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.