(85 days)
LDL-cholesterol test system is a device to measure LDL-cholesterol in serum. LDL-Cholesterol measurements are used in diagnosis and treatment of disorders of excess cholesterol in the blood and lipid and lipoprotein metabolisms disorders.
The Wako Direct LDL-C test is an in vitro diagnostic assay for the quantitative determination of low density lipoprotein cholesterol in serum.
Here's an analysis of the provided text to extract the requested information about the Wako Direct LDL-C test:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to a predicate device and a reference method. The key performance metrics are correlation coefficients and regression equations.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Equivalent LDL Direct Liquid Select Cholesterol reagent) | - Serum samples: Correlation coefficient = 0.986; Regression equation (y = Wako Direct LDL-C, x = Predicate) = 1.018x + 0.135 - Plasma samples: Correlation coefficient = 0.988; Regression equation (y = Wako Direct LDL-C, x = Predicate) = 0.98x + 4.18 |
| Performance against reference method ("beta quantification" involving ultracentrifugation) | - Serum samples: Correlation coefficient = 0.983; Regression equation (y = Wako Direct LDL-C, x = Reference) = 0.97x + 5.12 |
| Precision | "Precision studies indicate acceptable values can be obtained on a day to day basis." (No specific quantitative criteria or results provided beyond this statement). |
| Minimum detectable level | 1 mg/dL |
2. Sample Sizes and Data Provenance
The document does not explicitly state the sample sizes used for the comparison studies (test set). It mentions "serum and plasma samples" for predicate comparison and "serum samples" for reference method comparison, but no specific number of samples.
The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts and Qualifications for Ground Truth Establishment
This information is not provided. The study relies on comparisons to a predicate device and a "reference method" (beta quantification), which are themselves laboratory procedures, not expert visual assessments.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory assay, not a study involving human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC study was not done. This type of study is typically for evaluating devices that assist human readers in interpreting images or other data, which is not the function of this direct LDL-C measurement assay.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are standalone performance studies. The Wako Direct LDL-C test is an automated in vitro diagnostic assay that directly measures LDL-C in a sample. Its performance is evaluated independently against a predicate device and a reference method. There is no human-in-the-loop component for the measurement itself.
7. Type of Ground Truth Used
The ground truth for the comparison studies was:
- Predicate Device Performance: The results obtained from the "Equal LDL Direct Liquid Select Cholesterol reagent."
- Reference Method Performance: The results obtained from the "beta quantification" method, which involves ultracentrifugation. This is generally considered the gold standard laboratory method for LDL-C.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or "training data." This device is a biochemical assay, not a machine learning algorithm that typically requires a distinct training phase. The development of the assay itself would have involved extensive R&D and optimization, but those details are not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
As there's no explicitly mentioned "training set" in the context of a machine learning algorithm, this question is not directly applicable. If one considers the development and optimization of the assay, the "ground truth" during that phase would have involved established chemical and biochemical principles, validation against known standards, and potentially experiments comparing early versions of the assay to existing methods (like the Friedwald formula or beta quantification). However, the document does not detail this developmental process.
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SEP 2 2 1998
Wak
Wako Chemicals USA, Inc. 1600 Bellwood Road, Richmond, VA 23237 U.S.A.
510(k) Summary of Safety and Effectiveness
The Wako Direct LDL-C test is an in vitro diagnostic assay for the quantitative determination of low density lipoprotein cholesterol in serum.
Summary:
Blood total cholesterol levels have long been known to be related to coronary heart disease (CHD). In recent years, in addition to total cholesterol, LDL-C has become an important tool used to assess an individual risk of developing CHD since a strong positive relationship between LDL-C concentration and the incidence of CHD was reported. Thus, there has been substantial interest in LDL-C measurements, and most clinical laboratories routinely perform LDL-C analysis.
The currently accepted reference method is generally referred to as "beta quantification"24. which involves ultracentrifugation. Because this method is labor intensive and technique dependent, it is generally not used for routine testing. The Friedwald formula is most commonly used for routine purposes. However, since formula estimates LDL-C from measurements of total cholesterol, triglyceride and high density lipoprotein cholesterol (HDL-C), the LDL-C calculation depends on the accuracy and precision of the three measurements. The Wako L-type LDL-C test is a homogeneous assay, which eliminates the preparatory steps or calculation, and thus, can be applied to automated analyzers.
Principle:
When the sample is mixed with R1, the protecting reagent binds to LDL and protects LDL from enzyme reactions. Cholesterol esterase (CHE) and cholesterol oxidase (CO) react with non-LDL lipoproteins (chylomicron (CM), very low density lipoprotein (VLDL) and HDL). Hydrogen peroxide produced by the enzyme reactions with non-LDL cholesterol is decomposed by a catalase in Reagent 1. When Reagent 2 is added, the protecting reagent is removed from LDL and catalase in inactivated by sodium azide (NaN3). In this second process, CHE and CO react only with LDL-C. Hydrogen peroxide produced by the enzyme reactions with LDL-C yields a color complex upon oxidase condensation with N-(2-hydroxy-3-sufopropyl)-3,5-dimethoxyaniline {HDAOS} and 4aminoantipyrine (4AA) in the presence of peroxidase (POD). By measuring the absorbance of the blue color complex produced, at approximately 600nm, the LDL concentration in the sample can be calculated.
The safety and effectiveness of the Wako Direct LDL assay is demonstrated by its substantial equivalency to the Equal LDL Direct Liquid Select Cholesterol reagent. Both test systems are used to measure low density lipoprotein cholesterol in serum. In comparison studies against the predicate assay, a correlation coefficient of 0.986 and a regression equation of y =1.018x + 0.135 and a correlation coefficient of 0.988 and a regression equation of 0.98x + 4.18 were obtained for serum and plasma samples, respectively. In comparison studies against the reference method, a correlation coefficient of 0.983 and a regression equation of y = 0.97x + 5.12 was obtained for serum
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samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 1 mg/dL.
References
- Burtis, C.A. and Ashwood, E.R., Tietz Textbook of Clinical Chemistry. 2nd Ed., 1. Saunders, Philadelphia, 1994.
- Rifai, N., Warnick, G.R. and Dominiczak, M.H., Ed. Handbook of Lipoprotein 2. Testing. AACC Press, Washington, DC, USA, 1997.
- Friedwald, W.T., Levy, R.I. and Fredrickson, D.S. Estimation of the concentration 3. of low density lipoprotein cholesterol in plasma without use of the centrifuge. Clin. Chem. 18, 449-502 (1972).
Tung Mallory
September 14, 1998 Wako Diagnostics Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, VA 23237
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 2 1998
Tonya Mallory · Senior Manager Wako Chemicals USA, Inc. 1600 Bellwood Road Richmond, Virginia 23237
Re : K982271 Wako Direct LDL-C Regulatory Class: I Product Code: MRR Dated: June 8, 1998 Received: June 29, 1998
Dear Ms. Mallory:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531… through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_ of
1982291 510(k) Number (if known):_ Wako Divilet LDL-C Device Name:
Indications For Use:
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.
O
OR
Over-The-Counter Use
(Optional Format 1-2-9
§ 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.