(158 days)
No
The device description and performance studies focus on standard immunonephelometry techniques and do not mention any AI or ML components.
No
The device is an in-vitro diagnostic reagent used for quantitative determination of free light chains, which aids in the diagnosis of certain conditions, rather than treating them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the assays are "In-vitro diagnostic reagents" and that "FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL)." This clearly indicates its role in diagnosis.
No
The device is described as in vitro diagnostic reagents and associated controls and standards used with specific hardware systems (BN II and BN ProSpec Systems) for performing particle-enhanced immunonephelometry. This involves physical reagents and a hardware-based measurement process, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC)... in human serum and EDTA plasma". It also states that these measurements are used "as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL)". This clearly indicates the device is intended for use in examining specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description further reinforces this by detailing the reagents and their use in "in vitro diagnostic reagents for the quantitative determination of free light chains... in human serum and EDTA plasma". It also describes the mechanism of action (particle-enhanced immunonephelometry) which is a common technique used in IVD testing.
- Components: The description lists various components like "N Latex FLC kappa and lambda assays", "N FLC Supplementary Reagent", "N FLC Standard SL", and "N FLC Controls SL1 and SL2". These are all typical components of an IVD test system used for performing the diagnostic assay.
- Clinical Studies and Performance Metrics: The inclusion of sections on "Clinical Studies" and "Key Metrics" (Sensitivity, Specificity) further confirms its nature as an IVD, as these are standard evaluations for demonstrating the performance of a diagnostic device.
- Predicate Device(s): The mention of predicate devices with K numbers (K031016) indicates that this device is being compared to previously cleared IVD devices.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
N Latex FLC kappa and N Latex FLC lambda assays: In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particleenhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL).
N FLC Supplementary Reagent: Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA).
N FLC Standard SL: Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems.
N FLC Control SL1 and SL2: The N FLC Controls SL1 and SL2 are for use as assaved accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems.
Special Conditions for Use: For prescription use only. Special instrument requirements: BN II (K943997) and BN ProSpec Systems (K001647)
Product codes (comma separated list FDA assigned to the subject device)
DFH, DEH, JIX, JJY
Device Description
The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® Systems. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL).
Used in conjunction with the assay reagents, N FLC Standard SL is for use in the establishment of reference curves for the determination of free light chains, type kappa and type lambda on the BN™ II and BN ProSpec® Systems. The N FLC Control SL 1 and 2 products are for use as assayed accuracy controls and precision controls in the determination of free light chains, type kappa and type lambda by immunonephelometry with the BN™ II and BN ProSpec® Systems.
The FLC test systems are based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with monoclonal antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated when mixed with samples containing FLC. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
Mentions image processing
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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
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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)
Precision and Reproducibility: Evaluated according to Clinical and Laboratory Standards Institute EP05-A3 guideline. Serum samples from commercial sources, pooled to achieve target concentrations spanning the linear range. Testing on three BN II and three BN ProSpec® instruments with two replicates per run, two runs per day using three lots of assay-specific reagents. Results summarized by mean (mg/L) and Coefficient of Variation (%).
Measuring Range (Linearity and LoQ): Linearity studies performed according to CLSI EP06-A: 2003. Test specimens serially diluted to yield a minimum of 9 levels within the claimed measuring range. Serum and EDTA plasma from four healthy donors (Sanquin blood bank) spiked with purified polyclonal FLC kappa and FLC lambda, then diluted with FLC depleted plasma. Measured in three independent measurements. Limit of Quantitation (LoQ) studies performed in accordance with CLSI EP17-A2: 2012. Five individual serum samples with very low concentrations of FLC kappa and five with very low concentrations of FLC lambda diluted with PBS containing 1% human serum albumin (HSA). Samples run 10 times on two lots of reagents, on two systems (BN II and BN ProSpec), on three consecutive days.
High Dose Hook Effect (Antigen Excess): Serum samples with high FLC concentrations manually diluted. When pre-reaction bit values are higher than the upper end of the calibration curve, new dilution and measurement initiated automatically by the system. No hook effect (false negatives) observed for FLC kappa up to 27,100 mg/L and FLC lambda up to 57,300 mg/L due to built-in pre-reaction protocols.
Specificity (Interference): Evaluated according to CLSI guideline EP7-A210. Various endogenous and exogenous substances tested for interference.
Clinical Studies - Expected values / Reference interval: Reference interval study performed according to CLSI EP28-A3C. Determined from a US-population of 201 apparently healthy subjects. Intervals calculated non-parametrically, representing the central 95% range. Kappa: 8.24–28.9 mg/L; Lambda: 9.10–32.6 mg/L. Ratio: 0.53 to 1.51 (median 0.88).
Clinical Sensitivity and Specificity: Total of 342 samples included (96 Multiple Myeloma, 83 AL Amyloidosis, 163 non-myeloma).
For Multiple Myeloma: Clinical Sensitivity: 95.8 % (95 % Confidence Interval: 89.8 to 98.4 %). Clinical Specificity: 96.9 % (95 % Confidence Interval: 93.0 to 98.7 %).
For AL Amyloidosis: Clinical Sensitivity: 83.1 % (95 % Confidence Interval: 73.7 to 89.7 %). Clinical Specificity: 96.9 % (95 % Confidence Interval: 93.0 to 98.7 %).
Method comparison with predicate device: 152 serum samples from patients with monoclonal gammopathy assayed by immunofixation (IFE), N Latex FLC, and a comparison method (commercially available particle-enhanced immunonephelometric method). Overall agreement rate for N Latex FLC kappa versus Comparison Method and N Latex FLC lambda versus Comparison Method.
Key results:
Precision: Total CV for kappa ranged from 3.45% to 7.87%, for lambda 2.87% to 9.44%.
Linearity: Supports claims of 3.4 to 110 mg/L for FLC kappa and 1.9 to 60 mg/L for FLC lambda.
LoQ: 0.195 mg/L for FLC kappa (total error 10.57%), 0.532 mg/L for FLC lambda (total error 10.01%).
High Dose Hook Effect: Not observed up to 27,100 mg/L (kappa) and 57,300 mg/L (lambda).
Specificity: No interference found from listed endogenous and exogenous substances up to indicated concentrations.
Reference Intervals: Kappa: 8.24–28.9 mg/L; Lambda: 9.10–32.6 mg/L; Ratio: 0.53 to 1.51.
Clinical Performance: High sensitivity and specificity for Multiple Myeloma and AL Amyloidosis diagnosis.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Clinical Sensitivity:
Multiple Myeloma: 95.8 % (95 % Confidence Interval: 89.8 to 98.4 %)
AL Amyloidosis: 83.1 % (95 % Confidence Interval: 73.7 to 89.7 %)
Clinical Specificity:
Multiple Myeloma: 96.9 % (95 % Confidence Interval: 93.0 to 98.7 %)
AL Amyloidosis: 96.9 % (95 % Confidence Interval: 93.0 to 98.7 %)
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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§ 866.5550 Immunoglobulin (light chain specific) immunological test system.
(a)
Identification. An immunoglobulin (light chain specific) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques both kappa and lambda types of light chain portions of immunoglobulin molecules in serum, other body fluids, and tissues. In some disease states, an excess of light chains are produced by the antibody-forming cells. These free light chains, unassociated with gamma globulin molecules, can be found in a patient's body fluids and tissues. Measurement of the various amounts of the different types of light chains aids in the diagnosis of multiple myeloma (cancer of antibody-forming cells), lymphocytic neoplasms (cancer of lymphoid tissue), Waldenstrom's macroglobulinemia (increased production of large immunoglobulins), and connective tissue diseases such as rheumatoid arthritis or systemic lupus erythematosus.(b)
Classification. Class II (performance standards).
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November 17, 2017 Siemens Healthcare Diagnostics Products GmbH Christine Perkins Regulatory Specialist Emil-von-Behring-Str. 76 Marburg, DE 35041
Re: K171742
Trade/Device Name: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2 Regulation Number: 21 CFR 866.5550 Regulation Name: Immunoglobulin (light chain specific) immunological test system Regulatory Class: Class II Product Code: DFH, DEH Dated: October 19, 2017 Received: October 20, 2017
Dear Christine Perkins:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kelly Oliner
For, Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171742
Device Name
N Latex FLC kappa, N Latex FLC lambda; N FLC Standard SL; N FLC Control SL1 and SL2
Indications for Use (Describe) N Latex FLC kappa and lambda assays:
In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL). N FLC Supplementary Reagent:
Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems.
A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA). N FLC Standard SL:
Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems.
N FLC Controls SL1 and SL2:
The N FLC Controls SL1 and SL2 are for use as assayed accuracy controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary per 21 CFR 807.92
This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
The assigned 510(k) number is: ______K171742 _________________________________________________________________________________________________________________________________
5.1 Submitter
Siemens Healthcare Diagnostics Products GmbH Emil-von-Behring-Str. 76 35041 Marburg, Germany
| Contact Person: | Christine Perkins |
|---|---|
| Email: | christine.perkins@siemens.com |
| Phone: | 302-631-8811 |
| Fax: | 302-631-6299 |
| Date of Preparation: | November 14, 2017 |
5.2 Device Information
| Trade Name: | N Latex FLC kappa assay
N Latex FLC lambda assay |
|-----------------------|------------------------------------------------------------------------------------------|
| Common or Usual Name: | Light Chain immunological test system |
| Classification Name: | Immunoglobulin (light chain specific)
immunological test system per 21CFR
866.5550 |
| Product Code: | DFH (kappa)
DEH (lambda) |
| Regulatory Class: | II |
| 510(k) Review Panel: | Clinical Immunology (82) |
| Trade Name: | N FLC Standard SL |
| Common or Usual Name: | Calibrator, Multi-Analyte Mixture
per 21 CFR 862.1150 |
| Product Code: | JIX |
4
| Regulatory Class:
510(k) Review Panel: | II
Clinical Chemistry (82) |
|-----------------------------------------------------|--------------------------------------------------------------------------|
| Trade Name:
Common or Usual Name: | N FLC Control SL1 & SL2
Multi-Analyte Controls
per 21 CFR 862.1660 |
| Product Code:
Regulatory Class:
510(k) Panel: | JJY
I
Clinical Chemistry (82) |
5.3 Predicate Devices
The Binding Site Freelite® Human Kappa Free Kit for use on the Siemens BN™ II - K031016
The Binding Site Freelite® Human Lambda Free Kit for use on the Siemens BN™ II - K031016
5.4 Device Description / Test Principle
The N Latex FLC (free light chain) assays are in vitro diagnostic reagents for the quantitative determination of free light chains, type kappa or type lambda, in human serum and EDTA plasma by means of particle-enhanced immunonephelometry using the BN™ II and BN ProSpec® Systems. Used in conjunction with other clinical and laboratory findings, FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL).
Used in conjunction with the assay reagents, N FLC Standard SL is for use in the establishment of reference curves for the determination of free light chains, type kappa and type lambda on the BN™ II and BN ProSpec® Systems. The N FLC Control SL 1 and 2 products are for use as assayed accuracy controls and precision controls in the determination of free light chains, type kappa and type lambda by immunonephelometry with the BN™ II and BN ProSpec® Systems.
The FLC test systems are based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with monoclonal antibodies to human free light chains, type kappa or lambda, respectively, are agglutinated when mixed with samples containing FLC. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.
5
5.5 Intended Use / Indications for Use
N Latex FLC kappa and N Latex FLC lambda assays
In-vitro diagnostic reagents for the quantitative determination of free light chains (FLC), type kappa or type lambda in human serum and EDTA-plasma by means of particleenhanced immunonephelometry using the BN Systems. FLC measurements are used as an aid in the diagnosis of multiple myeloma (MM) and amyloidosis (AL).
N FLC Supplementary Reagent
Supplementary reagent for the immunonephelometric determination of free light chains (FLC), type kappa and type lambda on BN Systems. A mixture of both supplementary reagents is used to suppress interference by rheumatoid factors and human anti-mouse antibodies (HAMA).
N FLC Standard SL
Establishment of reference curves for the determination of free light chains (FLC), type kappa and type lambda on the BN Systems.
N FLC Control SL1 and SL2
The N FLC Controls SL1 and SL2 are for use as assaved accuracy controls and precision controls in the determination of free light chains (FLC), type kappa and type lambda by immunonephelometry with the BN Systems.
Special Conditions for Use:
For prescription use only.
Special instrument requirements:
BN II (K943997) and BN ProSpec Systems (K001647)
6
Comparison of Technological Characteristics
| Siemens Healthcare | Binding Site Predicate | |
|---|---|---|
| Device | ||
| N Latex FLC kappa | ||
| N Latex FLC lambda | Freelite® Human Kappa Free | |
| and Freelite® Human Lambda | ||
| Free kits on the Siemens | ||
| BNTMII | ||
| K031016 | ||
| Indications for | ||
| Use | In-vitro diagnostic reagents for the | |
| quantitative determination of free | ||
| light chains (FLC), type kappa or | ||
| type lambda, in human serum and | ||
| EDTA plasma by means of particle- | ||
| enhanced immunonephelometry | ||
| using the BN Systems. FLC | ||
| measurements are used as an aid in | ||
| the diagnosis of multiple myeloma | ||
| (MM) and amyloidosis (AL). | Kappa: This kit is intended for the | |
| quantitation of kappa free light chains | ||
| in serum and urine on the Siemens | ||
| BNTM II. Measurement of free light | ||
| chains aids in the diagnosis and | ||
| monitoring of multiple myeloma, | ||
| lymphocytic neoplasms, | ||
| Waldenstrom's macroglobulinemia, | ||
| AL amyloidosis, light chain | ||
| deposition disease and connective | ||
| tissue diseases such as systemic | ||
| lupus erythematosus in conjunction | ||
| with other laboratory and clinical | ||
| findings. | ||
| Lambda: This kit is intended for the | ||
| quantitation of lambda free light | ||
| chains in serum and urine on the | ||
| Siemens BNTM II. Measurement of | ||
| free light chains aids in the diagnosis | ||
| and monitoring of multiple myeloma, | ||
| lymphocytic neoplasms, | ||
| Waldenstrom's macroglobulinemia, | ||
| AL amyloidosis, light chain | ||
| deposition disease and connective | ||
| tissue diseases such as systemic | ||
| lupus erythematosus in conjunction | ||
| with other laboratory and clinical | ||
| findings. | ||
| Sample Type | Human serum and EDTA plasma | Human serum and urine |
| Technology | Nephelometry | |
| Polystyrene particles coated with | ||
| monoclonal antibodies | Nephelometry | |
| Polystyrene particles coated with | ||
| polyclonal antibodies | ||
| Instrument | Siemens BN II and BN ProSpec | Siemens BN II |
| System | Systems | |
| Analytical | kappa: 3.4 to 110 mg/L | Kappa: 5.9 to 190 mg/L |
| measuring range | ||
| (Calibrator lot | ||
| dependent) | lambda: 1.9 to 60 mg/L | Lambda: 5.0 to 160 mg/L |
| Reference | kappa: 8.24 - 28.90 mg/L | Kappa: 3.30 to 19.40 mg/L |
| Interval | lambda: 9.10 - 32.60 mg/L | Lambda: 5.71 to 26.30 mg/L |
| Ratio: 0.53 to 1.51 | Ratio: 0.26 to 1.65 | |
| New Device | Predicate Device | |
| N FLC Standard SL for the BN Systems | Human Kappa Free Standard | |
| Human Lambda Free Standard | ||
| K031016 | ||
| Indications for Use | Establishment of reference curves for | |
| the determination of free light chains | ||
| (FLC), type kappa and type lambda on | ||
| the BN Systems. | Used for the establishment of | |
| reference curves for the determination | ||
| of Freelite® Kappa and Lambda light | ||
| chains on the BN II System. | ||
| Matrix | Consists of a stabilized liquid | |
| containing human free light chain | ||
| proteins, human serum albumin and | ||
| protease inhibitors. Contains sodium | ||
| azide ( 19.4 mg/L | total N | |
| 28.9 mg/L | 0 | 1 |
| total N | 9 | 35 |
N Latex FLC kappa versus Comparison Method
overall agreement rate:
N Latex FLC lambda versus Comparison Method
| Comparison
Method ⇒
N Latex FLC
lambda ↓ | 26.3mg/L | total N |
|---------------------------------------------------|----------|-----------------|-----------|---------|
| 32.6mg/L | 0 | 10 | 85 | 95 |
| total N | 22 | 43 | 87 | 152 |
overall agreement rate:
5.8 Proposed Labeling
The labeling is adequate and satisfies requirements of 21 CFR Part 809.10.
5.9 Traceability
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5.9.1 N FLC Standard SL
Calibration of the assay is traceable to an internal master calibrator; there is no international standard reference material.
5.9.2 N FLC Control SL1 and SL2
N FLC Controls are traceable to the master calibrator.