(83 days)
For in vitro diagnostic use in the quantitative measurement of lipoprotein(a) (Lp(a)) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat) metabolism and assessing persons at risk for cardiovascular diseases when used in conjunction with clinical evaluation and other lipoprotein tests.
The ADVIA® Chemistry Lipoprotein(a) calibrators is intended for use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry Lipoprotein(a) (LPA) assay.
The Lipoprotein(a) reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Lipoprotein(a) calibrator is a single analyte, human serum based product containing human lipoprotein (a). The kit consists of 1 vial each of 5 calibrator levels which are lyophilized. The target concentrations of these calibrators are 7.5, 15, 30, 65, and 95 mg/dL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
Here's a breakdown of the acceptance criteria and study details for the ADVIA® Chemistry Lipoprotein(a) Assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state formal "acceptance criteria" in a definitive, quantified table for all performance characteristics. Instead, it describes studies that "gave acceptable results when compared to the predicate device" and lists the numerical outcomes of these studies. Therefore, this table is constructed by inferring the implied acceptance from the reported "acceptable results" and direct comparisons to the predicate device where available.
| Performance Characteristic | Implied Acceptance Criteria (from predicate similarity/acceptable results) | Reported Device Performance (ADVIA Chemistry Lipoprotein(a) Assay) |
|---|---|---|
| Precision | Within acceptable variability for a diagnostic assay, comparable to predicate. (Precise numerical criteria not explicitly stated but implied by acceptable results) | Within Run CV: 0.9% - 1.2% (lower concentrations), 0.8% (higher concentration) Total CV: 1.3% - 1.6% (lower concentrations), 1.6% (higher concentration) |
| Linearity/Reportable Range | Linear performance across the intended measuring range. | Linear/measuring range: 10.00 mg/dL - 85.00 mg/dL |
| Limit of Blank (LoB) | Below 6.0 mg/dL (claim supported) | 5.35 mg/dL |
| Limit of Detection (LoD) | Below 9.0 mg/dL (claim supported) | 8.90 mg/dL |
| Limit of Quantitation (LoQ) | Below 10.0 mg/dL (claim supported) | 9.02 mg/dL |
| Method Comparison (Serum) | Strong correlation (R > 0.99) and agreement with predicate device. Slope and intercept confidence intervals encompassing 1 and 0 respectively for good agreement. | Correlation Coefficient: 0.99 Linear Regression (y = mx + b): y = 1.01x - 1.02 mg/dL Slope 95% CI: 1.00 - 1.02 Intercept 95% CI: -1.47 - -0.57 |
| Matrix Comparison (Plasma) | Strong correlation (R > 0.99) and agreement with predicate device. Slope and intercept confidence intervals encompassing 1 and 0 respectively for good agreement. | Correlation Coefficient: 0.99 Linear Regression (y = mx + b): y = 1.01x - 0.98 mg/dL Slope 95% CI: 0.99 - 1.02 Intercept 95% CI: -1.49 - -0.47 |
| Analytical Specificity | No significant interference (>10% variance) from common interferents (icterus, lipemia, hemolysis) at specified concentrations. | No significant interference found at: - Unconjugated bilirubin: 0-60 mg/dL - Conjugated bilirubin: 0-60 mg/dL - Intralipid: 0-1000 mg/dL - Hemoglobin: 0-1000 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
- Precision: Not explicitly stated as a separate "test set" for precision, but studies used:
- Serum sample pools and serum-based controls.
- Each sample assayed 2 replicates per run, 2 runs per day, for at least 20 days.
- Linearity/Assay Reportable Range:
- Sample Size: Nine diluted samples (prepared from high and low serum pools).
- Limit of Blank, Limit of Detection, Limit of Quantitation:
- Sample Size: 160 replicates of "zero" serum pool and several serum pools (number not specified) with Lp(a) concentrations up to 4x LoD level.
- Method Comparison (Serum):
- Sample Size: 68 serum samples.
- Matrix Comparison (Plasma):
- Sample Size: 44 plasma samples.
- Analytical Specificity:
- Specific concentrations of interferents (unconjugated bilirubin 0-60 mg/dL, conjugated bilirubin 0-60 mg/dL, Intralipid 0-1000 mg/dL, hemoglobin 0-1000 mg/dL) were tested with samples at 3 specific Lp(a) levels (e.g., 14, 28, 47 mg/dL for bilirubin). The exact number of individual samples/replicates isn't specified beyond "in 14, 28, and 47 mg/dL lipoprotein (a) samples."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The samples are referred to as "human serum" or "human plasma."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of blood assay does not typically use human experts to establish "ground truth" in the same way an imaging device or AI algorithm would. Instead, the ground truth for an in vitro diagnostic assay is established through:
- Reference Methods: Comparison against an established, legally marketed (predicate) device.
- Known Concentrations: Use of accurately prepared and characterized calibrators and controls with known concentrations of the analyte.
- Spiking Experiments: Addition of known amounts of interferents or analyte to assess impact.
The document implicitly relies on the predicate device (Randox Lipoprotein (a) assay on the Hitachi 717) as a "ground truth" reference for method and matrix comparison studies.
4. Adjudication Method for the Test Set
Not applicable. The "test set" here refers to clinical samples or control materials analyzed by the device, and their values are compared against a predicate device or expected values, not adjudicated by experts in a qualitative sense.
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 an in vitro diagnostic assay for quantitative measurement of a biomarker, not an imaging device or an AI application that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this entire submission describes the standalone performance of the ADVIA Chemistry Lipoprotein(a) assay. The device measures Lp(a) concentration directly on the ADVIA Chemistry systems without human interpretation or intervention in the measurement process itself, other than preparing samples and operating the instrument.
7. The Type of Ground Truth Used
The ground truth used for performance validation is primarily:
- Predicate Device Measurements: For method and matrix comparisons, the results from the legally marketed Randox Lipoprotein(a) assay on the Hitachi 717 are considered the comparative "ground truth" for demonstrating substantial equivalence.
- Known Concentrations/Prepared Samples: For linearity, LoB/LoD/LoQ determinations, and analytical specificity, samples with known concentrations (e.g., "zero" serum pool, serum pools with Lipoprotein (a) concentration up to 4 x LOD level, diluted samples with expected values, samples with spiked interferents) serve as the ground truth.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. This device is a classical in vitro diagnostic immunoassay, not an AI algorithm that requires training data. The development and calibration of such assays involve extensive R&D, but the data used in those phases are not typically referred to as a "training set" in this manner.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the AI/machine learning sense for this device. The development of the assay's reagents and methodologies would have involved established chemical and immunological principles, and calibration of the assay (using the ADVIA Chemistry Lipoprotein(a) calibrator) uses products with assigned Lp(a) concentrations.
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DEC 2 0 2012
510(k) Summary of Safety and Effectiveness for the ADVIA® Chemistry Lipoprotein(a) Assay
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.
K123046 A. 510(k) Number:
B. Date of Preparation: 09/25/2012
C. Proprietary and Established Names:
ADVIA® Chemistry Lipoprotein(a) (LPA) Assay ADVIA® Chemistry Lipoprotein(a) Calibrator
D. Applicant
| Contact: | Neil ParkerRegulatory Affairs |
|---|---|
| Address: | Siemens Healthcare Diagnostics, Inc511 Benedict Ave,Tarrytown, NY 10591 |
| Phone: | (914) 524-2477 |
E. Regulatory Information:
Reagent
-
- Regulation section: 21 CFR $866.5600, LOW DENSITY LIPOROTEIN IMMUNOLOGICAL TEST SYSTEM
-
- Classification: Class II
-
- Product Code: DFC
-
- Panel: Immunology
- Calibrator
-
- Regulation section: 21 CFR §862.1150, Calibrator, secondary
-
- Classification: Class II
-
- Product Code: JIT
-
- Panel:
Siemens Healthcare Diagnostics, Inc. ADVIA® Chemistry Lipoprotein(a) Assay Premarket Notification 510(k) - 510(k) Summary Page 1 of 7
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Clinical Chemistry
F. Predicate Device:
Reagent
-
- Device Name: Randox Lipoprotein (a) assay
-
- Common Name: Randox Lipoprotein (a) assay
-
- 510(k) Number: K011568
-
- Manufacturer: Randox Laboratories, Ltd. Uk.
Calibrator
-
- Device Name: Randox Lipoprotein(a) Calibrator Series
-
- Common Name: Randox Lipoprotein(a) Calibrator Series
-
- 510(k) Number: K011568
-
- Manufacturer: Randox Laboratories, Ltd. UK.
G. Intended Use:
The ADVIA® Chemistry Lipoprotein (a) assay is for in vitro diagnostic use in the quantitative measurement of lipoprotein(a) (Lp(a)) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat) metabolism and assessing persons at risk for cardiovascular diseases when used in conjunction with clinical evaluation and other lipoprotein tests.
The ADVIA Chemistry Lipoprotein (a) calibrator is for in vitro diagnostic use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry Lipoprotein(a) (LPA) assay.
H. Device Description:
The Lipoprotein(a) reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry system. They are supplied as a 100 tests/wedge, 2 wedges/kit. ADVIA Chemistry Lipoprotein(a) calibrator is a single analyte, human serum based product containing human lipoprotein (a). The kit consists of 1 vial each of 5 calibrator levels which are lyophilized. The target concentrations of these calibrators are
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7.5, 15, 30, 65, and 95 mg/dL. The volume per vial (after reconstitution with deionized water) is 1.0 mL. Deionized water is recommended to be used as a zero calibrator.
l. Test Principle:
In the ADVIA Chemistry Lipoprotein(a) assay, sample is diluted and then mixed with the R1 reagent (a buffer), followed by an addition of the R2 reagent (which contains latex particles coated with antibodies specific for Lipoprotein (a). The formation of the antibody-antigen complex during the reaction results in an increase in turbidity. This turbidity is measured at 694 nm. By constructing a standard curve from the absorbance of standards, Lipoprotein (a) concentration of a sample can be determined. Increasing Lipoprotein (a) results in increasing turbidity.
J. Substantial Equivalence Information:
| Item | New Device:ADVIA 1650 ChemistryLipoprotein(a) | Predicate Device:Randox Lipoprotein(a) assay |
|---|---|---|
| Analyte | lipoprotein (a) | Same |
| IntendedUse/Indications for Use | is for in vitro diagnostic use inthe quantitative measurementof lipoprotein(a) (Lp(a)) inhuman serum or plasma onthe ADVIA Chemistrysystems. Measurement ofLp(a) may aid in the diagnosisof disorders of lipid (fat)metabolism and assessingpersons at risk forcardiovascular diseases whenused in conjunction withclinical evaluation and otherlipoprotein tests. | Same - Immunoturbidimetricassay for the quantitative invitro determination ofLipoprotein(a) in humanserum or plasma.This product is suitable foruse on the Hitachi 717analyser. |
| Measurement | quantitative | Same |
| Sample type | SerumLithium Heparin Plasma | SerumLithium Heparin, Sodium EDTAplasma |
| Format | Liquid | Liquid |
| Use of Calibrators | Yes | Yes |
| Analytical measuringinterval | 10.00 mg/dL- 85.00 mg/dL | 2-90 mg/dL |
| Method Principle | latex-particle-enhanced immuno-tubidimetric | latex-particle-enhanced immuno-tubidimetric |
| Reagents | Two | Two |
Reagent
Siemens Healthcare Diagnostics, Inc. ADVIA® Chemistry Lipoprotein(a) Assay Premarket Notification 510(k) - 510(k) Summary
Page 3 of 7
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| R1 and R2 | R1 and R2 | |
|---|---|---|
| Instrument to be used | ADVIA 1650 Chemistry | Hitachi 717 Analyzer |
Calibrator
| Item | New Device:ADVIA Chemistry Lipoprotein(a)calibrator | Predicate Device:Randox Lipoprotein(a)Calibrator Series |
|---|---|---|
| Intended Use | For in vitro diagnostic use in thecalibration of ADVIA® Chemistrysystems for the ADVIA ChemistryLipoprotein(a) (LPA) assay. | Same - For use in thecalibration of Lipoprotein(a)assays |
| Measured Analytes(value assigned) | lipoprotein (a) | Same |
| Form | Lyophilized | Same |
| Matrix | Human serum | Same |
| Analyte source | Derived from human source | Same |
| Number of levels | Six (the lowest level is a zero-level, not included) | Same |
| Fill Volume | 1.0 mL each vial | Same |
| Shelf Life Stability | 36 months at 2-8°C | Same |
| Open Vial stability | 14 days at 2-8°C | Same |
K. Standard/Guidance Document Reference
- Interference Testing in Clinical Chemistry; Approved Guideline Second Edition . (CLSI EP07-A2)
- Protocols for Determination of Limits of Detection and Limits of Quantitation; . Approved Guideline (CLSI EP17-A)
- . Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline-Second Edition (CLSI EP05-A2)
L. Performance Characteristics
All studies were performed using the ADVIA 1650 Chemistry System.
Substantial equivalence was demonstrated by testing several performance characteristics including imprecision, method comparison, interfering substances and analytical range. All of the evaluation studies gave acceptable results when compared to the predicate device. These studies support that the ADVIA® Chemistry Lipoprotein(a) assay is substantially equivalent to the predicate device.
Page 4 of 7
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Precision -
Within run and Total Precision were established by assaying serum sample pools and serum based controls. Each sample was assayed 2 replicates per run, 2 runs per day, for at least 20 days. Precision estimates were computed according to CLSI document EP05-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline.
| Within Run | Between Run | Between Day | Total | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | #Day | #Run | #Rep | MEAN | SD | CV | SD | CV | SD | CV | SD | CV |
| Serum Control | 20 | 40 | 80 | 14.17 | 0.12 | 0.9 | 0.12 | 0.8 | 0.08 | 0.5 | 0.19 | 1.3 |
| Serum Control | 20 | 40 | 80 | 18.44 | 0.14 | 0.7 | 0.12 | 0.6 | 0.07 | 0.4 | 0.20 | 1.1 |
| Serum Pool 1 | 20 | 40 | 80 | 49.75 | 0.40 | 0.8 | 0.43 | 0.9 | 0.30 | 0.6 | 0.66 | 1.3 |
| Serum Pool 2 | 20 | 40 | 80 | 83.67 | 1.03 | 1.2 | 0.85 | 1.0 | 0.00 | 0.0 | 1.34 | 1.6 |
II. Linearity/assay reportable range
A linearity study across the entire measuring range was assessed using nine diluted samples prepared from high and low serum pools by dilution. All samples were tested on the ADVIA Chemistry analyzer. The range of samples tested was from 7.75 -102.30 mg/dL. The observed values were compared to the expected values. Linear/measuring range of the assay is 10 to 85.0 mg/dL. The low end of the assay range is calculated based on the Limit of Quantitation. The high end of the assay range is based on the linearity calculation.
III. Limit of Blank, Limit of Detection, Limit of Quantitation
The estimations of the Limit of Blank (LoB), Limit of Detection (LoD) and Limit of Quantitation (LoQ) were performed according to CLSI guideline EP17-A, Protocols for Determination of Limits of Detection and Limits of Quantitation, by running 160 replicates of "zero" serum pool and several serum pools with Lipoprotein (a) concentration up to 4 x LOD level. Data (LoB = 5.35 mg/dL, LoD = 8.90 mg/dL and LoQ = 9.02 mg/dL) support the following claims LoB = 6.0 mg/dL, LoD = 9.0 mg/dL and LoQ = 10.0 mg/dL.
IV. Method and matrix comparison with predicate device
The performance of the ADVIA Chemistry Lipoprotein(a) assay (y) for serum samples was compared with the performance of Randox Lipoprotein(a) assay on the Hitachi 717 (x). sixty-eight serum samples were tested. The sample results ranged from 11.00 -81.60 mg/dL lipoprotein (a) (x), and gave a correlation coefficient of 0.99. The results calculated using least squares linear regression (18 replicate) are as follows:
Page 5 of 7
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ADVIA Chemistry Lipoprotein (a) = 1.01 (predicate device) - 1.02 mg/dL Slope 95%C1: 1.00 - 1.02 Intercept 95% CI: - 1.47 - - 0.57
V. Matrix comparison with predicate device
The performance of the ADVIA Chemistry Lipoprotein(a) assay (y) for plasma samples on ADVIA Chemistry was compared with the performance of Randox Lipoprotein(a) assay on the Hitachi 717 (x). Forty-four plasma samples were tested; the sample results ranged from 12.0 - 80.1 mg/dL Lipoprotein(a) (x), and gave a correlation coefficient of 0.99. The results calculated using linear regression (188 replicate) are as follows:
ADVIA Chemistry 1650 Lipoprotein(a) = 1.01 (predicate device) - 0.98 mg/dL Slope 95%CI: 0.99 - 1.02 Intercept 95% CI: -1.49 - - 0.47
VI. Analytical specificity
Interferences from icterus, lipemia and hemolysis were evaluated in the ADVIA Chemistry Lipoprotein (a) assay using a significance criterion of >10% variance from the control. No significant interference was found at unconjugated bilirubin levels from 0-60 mg/dL in 14, 28, and 47 mg/dL lipoprotein (a) samples. No significant interference was found at conjugated bilirubin levels from 0-60 mg/dL in 14, 28, and 46 mg/dL lipoprotein (a) samples. No significant lipemia interference was found at Intralipid levels from 0-1000 mg/dL in 13, 26, and 44 mg/dL lipoprotein (a) samples. No significant hemoglobin interference was found at hemoglobin levels from 0-1000 mg/dL in 18, 31, and 46 mg/dL lipoprotein (a) samples.
VII. Clinical Studies
Not applicable.
VIII. Clinical cut-off
Not applicable
Page 6 of 7
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L. Conclusion
The ADVIA Chemistry Lipoprotein(a) assay is substantially equivalent in principle and performance to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Randox Lipoprotein(a) Assay (K011568).
The ADVIA Chemistry Lipoprotein(a) calibrator is substantially equivalent in principle and performance to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Randox Lipoprotein(a) Calibrator Series (K011568).
Siemens Healthcare Diagnostics, Inc. ADVIA® Chemistry Lipoprotein(a) Assay Premarket Notification 510(k) - 510(k) Summary
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Image /page/7/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 20, 2012
Siemens Healthcare Diagnostics, Inc. c/o Neil Parker 511 Benedict Ave. Tarrytown, NY 10591
Re: K123046
Trade/Device Name: ADVIA Chemistry Lipoprotein(a) Assay
ADVIA Chemistry Lipoprotein(a) Calibrator
Regulation Number: 21 CFR 866.5600
Regulation Name: Low Density Lipoprotein Immunological Test System Regulatory Class: Class II Product Code: DFC, JIT Dated: September 25, 2012 Received: September 28, 2012
Dear Mr. Parker:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 – Neil Parker
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C.'Benson for
Courtney H. Lias, Ph.D Director
Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K123046
Device Name:
ADVIA® Chemistry Lipoprotein(a) Assay ADVIA® Chemistry Lipoprotein(a) Calibrator
Indications for Use:
For in vitro diagnostic use in the quantitative measurement of lipoprotein(a) (Lp(a)) in human serum or plasma on the ADVIA Chemistry systems. Measurement of Lp(a) may aid in the diagnosis of disorders of lipid (fat) metabolism and assessing persons at risk for cardiovascular diseases when used in conjunction with clinical evaluation and other lipoprotein tests.
The ADVIA® Chemistry Lipoprotein(a) calibrators is intended for use in the calibration of ADVIA® Chemistry systems for the ADVIA Chemistry Lipoprotein(a) (LPA) assay.
Prescription Use X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Bute Chealer
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) k12304.6
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
Identification. A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.(b)
Classification. Class II (performance standards).