(91 days)
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No
The device description details a series of enzymatic reactions and spectrophotometric measurement, which are standard biochemical assay techniques and do not involve AI or ML. The performance studies focus on traditional analytical metrics like precision and method comparison. There is no mention of AI, ML, or related concepts in the provided text.
No.
This device is a system reagent used for the quantitative determination of Triglyceride concentrations, which means it aids in diagnosis rather than providing direct therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that measurements of triglyceride are "used in the diagnosis and treatment of patients" for various medical conditions. This directly aligns with the definition of a diagnostic device.
No
The device description clearly outlines a series of enzymatic reactions and the use of reagents to measure triglyceride concentrations, indicating a chemical assay system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma". This is a classic example of an in vitro diagnostic test, as it analyzes a sample taken from the human body (serum and plasma) outside of the body to provide information for diagnosis and treatment.
- Indications for Use: The indications for use further solidify its IVD nature by listing various diseases and conditions where triglyceride measurements are used in diagnosis and treatment.
- Device Description: The description details a series of enzymatic reactions performed on the sample, which is characteristic of laboratory-based diagnostic testing.
- Sample Type: The device uses human serum and plasma, which are biological samples analyzed in vitro.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers
Product codes (comma separated list FDA assigned to the subject device)
CDT
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Adults
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics:
Precision AU400/400e: Sample 1 (Total CV% 2.58), Sample 2 (Total CV% 2.54), Sample 3 (Total CV% 2.41)
Precision AU600/640/640e: Sample 1 (Total CV% 1.65), Sample 2 (Total CV% 1.41), Sample 3 (Total CV% 1.46)
Precision AU2700/5400: Sample 1 (Total CV% 2.00), Sample 2 (Total CV% 1.72), Sample 3 (Total CV% 1.78)
Assay Range: 10 - 1000 mg/dL
Method Comparison: Intercept -0.871, Slope 1.011, R 1.000
Interfering Substances: AU400/400e/600/640/640e/2700/5400 - Ascorbate ≤ 5% up to 20 mg/dL, Bilirubin ≤ 3% up to 40 mg/dL, Hemolysis ≤ 3% up to 500 mg/dL
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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 America
3131 W Royal Lane
Irving, 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. |
|---|---|
| ----------------- | ---------------------------------------------------------------------------------------------------------------------------------- |
1
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 Trinder | |
| indicator system | Same | |
| Sample dilution | Not required | Same |
| Reagent Materials | Lipoprotein Lipase and coupling enzymes | |
| and co-factors | Same | |
| Traceability | College of American Pathology (CAP) | |
| Serum Lipid (RM016) # 2 | Same | |
| Reagent storage form | Liquid ready to use | Same |
| Reagent On Board | ||
| Stability | 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 of | |
| Triglyceride concentrations in human serum and plasma on | ||
| OLYMPUS analyzers | System reagent for the | |
| quantitative | ||
| determination of | ||
| Triglyceride | ||
| concentrations in | ||
| human serum on | ||
| OLYMPUS 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 at |
| approximately 520nm | ||
| Expected Values | Adults: 48 - 352mg/dL |
Triglyceride