(77 days)
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.
This response is based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear from 5 to at least 900 mg/dL | Linear from 5 to at least 900 mg/dL, with a span from 0 mg/dL to 930 mg/dL. Regression statistics forced through the origin: sy.x = 3.7 mg/dL, (Vitalab Recoveries) = 1.164 x (Dilution Factor), n = 44. |
| Precision (Within Run) | Implicitly comparable to predicate or acceptable for intended use | Serum 1 (mean 69 mg/dL): 1SD = 0.6, %CV = 0.9%Serum 2 (mean 291 mg/dL): 1SD = 1.6, %CV = 0.6%Serum 3 (mean 624 mg/dL): 1SD = 3.5, %CV = 0.6% |
| Precision (Total) | Implicitly comparable to predicate or acceptable for intended use | Serum 1 (mean 69 mg/dL): 1SD = 1.1, %CV = 1.6%Serum 2 (mean 291 mg/dL): 1SD = 4.4, %CV = 1.5%Serum 3 (mean 624 mg/dL): 1SD = 11.3, %CV = 1.8% |
| Method Comparison (Serum) | Low intercept, slope near 1, low sy.x (comparable to predicate) | Intercept: -4.0 mg/dL (-6.9 to 1.16 mg/dL 95% CI)Slope: 1.071 (1.059 to 1.083 95% CI)sy.x: 3.6 mg/dL |
| Method Comparison (Plasma) | Low intercept, slope near 1, low sy.x (comparable to predicate) | Intercept: -0.2 mg/dL (-2.4 to 2.1 mg/dL 95% CI)Slope: 1.068 (1.057 to 1.079 95% CI)sy.x: 3.6 mg/dL |
| Minimum Detection Limit | Clearly defined and adequately low for clinical use | 1 mg/dL (calculated as mean + 2 standard deviations of 30 replicate measurements of normal saline, where both mean and SD were 0 mg/dL. Rounded up due to assay's round-off error). |
| Onboard Reagent Stability | Total imprecision of triglycerides recoveries less than 2 mg/dL over 14 days | Documented by assay of serum controls over 14 days. Total imprecision of triglycerides recoveries was less than 2 mg/dL. |
| Calibration Stability | Total imprecision of triglycerides recoveries less than 2 mg/dL over 7 days | Documented by assay of serum controls over 7 days. Total imprecision of triglycerides recoveries was less than 2 mg/dL. |
| Reconstituted Calibrator Stability | Observed change in triglycerides concentration less than 5% and statistically insignificant over 3 days | Documented by assaying calibrators of increasing ages. The observed change in triglycerides concentration over three days was less than 5% and statistically insignificant. |
(Note: The "Acceptance Criteria (Implied)" column contains interpretations of what would generally be considered acceptable performance for such a device in comparison to a predicate, as explicit criteria are not always stated but inferred from the study design and conclusion of substantial equivalence.)
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity/Recovery: n = 44 (This sample size likely refers to dilution factors or individual measurements across the range). Provenance: Not explicitly stated, but likely laboratory-prepared standards or spiked samples.
- Precision:
- Serum 1: 60 replicates
- Serum 2: 60 replicates
- Serum 3: 60 replicates
Provenance: Commercially available control serum.
- Method Comparison:
- Serum samples: 59 specimens
- Heparinized plasma samples: 60 specimens
Provenance: Collected from adult patients. Country of origin not specified, but the submission is to the FDA, implying studies likely conducted in the US or internationally to US standards. Retrospective or prospective design is not explicitly stated, but the description "were collected from adult patients and were assayed for triglycerides" often implies a prospective or at least recently collected set of samples for the purpose of the study.
- Minimum Detection Limit: 30 replicate measurements of normal saline. Provenance: Laboratory materials.
- Onboard Reagent Stability & Calibration Stability: Not explicitly stated beyond "serum controls."
- Reconstituted Calibrator Stability: Not explicitly stated beyond "calibrators of increasing ages."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This device is a quantitative clinical chemistry assay. The "ground truth" for such assays is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on individual cases.
- In this case, the "ground truth" for the method comparison study was the results from "another commercially available method," which served as the reference standard for comparison. The predicate device, the Beckman Trighycerides Reagent Kit and Synchron Multi-Calibrator, also serves as a benchmark for substantial equivalence.
- Therefore, traditional "experts" like radiologists establishing ground truth for images are not applicable here. The "expertise" lies in the validated performance of the reference method and the established accuracy of commercially available control sera.
4. Adjudication Method for the Test Set:
- Not applicable. This is a quantitative chemical assay, not a subjective interpretation task that would typically involve adjudication by multiple experts. The comparison is statistical (Deming regression) between the new device and a reference method.
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 standalone in-vitro diagnostic (IVD) device for quantitative measurement of triglycerides, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, no MRMC study with human readers was conducted, and the concept of "improvement with AI vs without AI" does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this entire submission describes standalone performance studies for the Vitalab Triglycerides Reagent and Calibrator on the Vitalab Selectra Analyzer. The performance metrics (linearity, precision, method comparison, detection limit, stability) are all intrinsic to the device system itself, operating without direct human interpretive input influencing the quantitative result. The device outputs a numerical value for triglyceride concentration.
7. The Type of Ground Truth Used:
- Reference Method Comparison: For the method comparison studies, the "ground truth" was established by analyzing patient samples with "another commercially available method" (presumably a validated and accepted diagnostic method for triglycerides).
- Known Concentrations/Standards: For linearity and detection limit, the ground truth was based on known concentrations of standards or normal saline (effectively 0 mg/dL).
- Certified Control Sera: For precision and stability studies, commercially available control serum with established target values was used.
8. The Sample Size for the Training Set:
- This submission describes performance validation studies for an IVD reagent and calibrator. It does not mention any "training set" in the context of machine learning or AI algorithms. The assay procedure is based on a well-established lipase/GPO enzymatic reaction coupled to a Trinder indicator, not a statistical model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.
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Brea, CA 92821 T (714) 672-3553 F (714) 672-3554
Summary of 510(k) Safety and Effectiveness Information
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction and other diseases involving lipid metabolism, various of patents will unders, or for assessing of the risk of developing cardiovascular diseases. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.
The Vitalab Triglycerides Reagent Kit and Vitalab Serum Calibrator are substantially equivalent to the Beckman Trighycerides Reagent Kit, product no. 445850 and the Synchron Multi-Calibrator, product no. 442600, which are marketed by Beckman Coulter, Inc. of Brea, CA.
The effectiveness of Vitalab Triglycerides Reagent on the Vitalab Selectra is shown in the following studies.
The recovery of triglycerides using the Vitalab Triglycerides Reagent is linear from 5 to at least 900 mg/dL, as shown by the The recovery of the span from 0 mg/dL to 930 mg/dL triglycerides. Regression statistics, which are forced through the origin, compare standard recoveries to dilution factors. These statistics are shown below.
sy.x = 3.7 mg/dL, (Vitalab Recoveries) = 1.164 x (Dilution Factor), n = 44
Precision is demonstrated by the replicate assay of commercially available control serum. Precision statistics, calculated analogous to the method described in NCCLS Guideline EP3-T, are shown below.
| Sample | n | mean | Within Run | Total | ||
|---|---|---|---|---|---|---|
| 1SD | %CV | 1SD | %CV | |||
| Serum 1 | 60 | 69 | 0.6 | 0.9% | 1.1 | 1.6% |
| Serum 2 | 60 | 291 | 1.6 | 0.6% | 4.4 | 1.5% |
| Serum 3 | 60 | 624 | 3.5 | 0.6% | 11.3 | 1.8% |
Fifty nine serum specimens ranging from 56 to 519 mg/dL trig!ycerides and 60 heparinized plasma specimens ranging from 28 to 701 mg/dL triglycerides were collected from adult patients and were assayed for triglycerides using the Vitalab Selectra Analyzer and another commercially available method. Results were compared by Deming regression and the following statistics were obtained.
| Serum Correlation | ||
|---|---|---|
| Intercept | -4.0 mg/dL | -6.9 to 1.16 mg/dL |
| Slope | 1.071 | 1.059 to 1.083 |
| sy.x: | 3.6 mg/dL | |
| Plasma Correlation | ||
| Intercept | -0.2 mg/dL | -2.4 to 2.1 mg/dL |
| Slope | 1.068 | 1.057 to 1.079 |
| sy.x: | 3.6 mg/dL | |
| Where | x = Competitive Reagent Resultsy = Selectra Results |
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The claimed detection limit is documented through the repetitive assay of normal saline. The mean and standard deviation of a 30 replicate within run precision study are both 0 mg/dL. The minimum detection limit, calculated as the mean plus two a so replations of the recovery values, is rounded up to 1 mg/dL, which is the round-off error of the assay.
The 14 day onboard reagent stability and 7 day calibration stability claims are documented through the assay of serum controls over the claimed periods. In all cases, the total imprecision of triglycerides recoveries over the test periods are less than 2 mg/dL.
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The three day reconstituted stability claim for the calibrator is shown by assaying calibrators of increasing ages. The observed change in triglycerides concentration over three days was less than 5% and statistically insignificant.
Wynn Stocking Manager of Regulatory Affairs Clinical Data, Brea CA ... ...
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is black, and the text is also black.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 1 0 2004
Clinical Data, Inc. c/o: Mr. Ned E. Devine, Jr. Entela, Inc. 3033 Madison Avenue, SE Grand Rapids, MI 49548
Re: K034000
Trade/Device Name: Vitalab Triglycerides Reagent and Vitalab Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX; CDT Dated: February 23, 2004 Received: February 24, 2004
Dear Mr. Devinc:
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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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper MS, DVM.
Yean M. Cooper, MS, 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):
K03 4000
Device Name:
Vitalab Triglycerides Reagent and Vitalab Calibrator
Indications for Use:
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alek S
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K03 4000
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
§ 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.