(237 days)
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No
The description focuses on the hardware components and the HPLC methodology for separating and quantifying hemoglobin fractions. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function.
No
This device is an in vitro diagnostic (IVD) device used to measure HbA1c levels in blood, which aids in the diagnosis and monitoring of diabetes. It does not directly treat or prevent a disease, injury, or disability.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A1c (HbA1c)... This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes." This clearly indicates its diagnostic purpose.
No
The device description clearly outlines a physical hardware system including a sampling unit, liquid pump, column, detector, etc., which are components of an automated High Performance Liquid Chromatography (HPLC) system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for in vitro diagnostic use".
- Measurement of Analytes in Biological Specimens: The device measures "% hemoglobin A1c (HbA1c)" and "mmol/mo hemoglobin A1c" in "whole blood specimens". These are biological specimens, and HbA1c is an analyte.
- Aid in Diagnosis: The intended use also states that the test is to be used "as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes". This is a clear diagnostic purpose.
The device description further supports this by detailing the analytical method (HPLC) used to measure the HbA1c in the blood sample.
N/A
Intended Use / Indications for Use
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A Ic (HbA 1c) (DCCT/NGSP) and mmol/mo hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
Product codes
PDJ
Device Description
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A 1c (sA1c) percentage in whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer.
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses non-porous ion- exchange high performance liquid chromatography (HPLC) for rapid, accurate and precise separation of the stable form of HbA Ic from other hemoglobin fractions. The G8 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A 1a, A 1b, F, LA 1c, sA Ic, and A0. The separation is done by eluting the hemoglobins from the column with a stepwise elution of three elution buffers containing different salt concentrations. The result report includes a sample ID, date, percentage and retention time of each fraction, sA1c percentage and total A1 percentage (A1a + A1b + sA1c), along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Interference Study:
- Study Type: Interference study developed according to CLSI guideline EP7-A2.
- Key Results: Determined concentrations at which no significant interference was observed for various substances (Acetylated Hb, Albumin, Aldehyde Hb, Ascorbic Acid, Carbamylated Hb, Bilirubin C, Labile Hb, Lipemia, Rheumatoid Factor, Bilirubin F). Hemoglobin E (HbE) was identified as an interferent, and a flag will be displayed, with the HbA1c result not reported from the analyzer if HbE is suspected.
Hemoglobin Variant Interference Study:
- Number of Samples: 10 samples for each Hb variant (HbS, HbC, HbE, HbD, HbF, HbA2) at approximately 6% and ≥8% HbA1c.
- Key Results: HbS, HbC, HbD, HbF, and HbA2 showed no interference. HbE showed interference, and the analyzer flags samples suspected to contain HbE, not reporting the HbA1c result.
Precision Study:
- Study Type: Precision study developed with reference to CLSI protocol EP5-A2.
- Sample Size: Four concentrations of unaltered EDTA whole blood specimens.
- Methodology: Assayed with 3 lots and 3 instruments, 2 replicates in a single run, 2 times a day for 20 nonconsecutive days. Total of 40 runs and 80 determinants for each data set.
- Key Results:
- Within-run Precision (Intra-assay): Coefficient of Variation (CV) ranged from 0.18% to 1.00% across tested HbA1c concentrations (approx. 5%, 6.5%, 8%, 12%).
- Total Precision: Coefficient of Variation (CV) ranged from 0.68% to 1.83% across tested HbA1c concentrations (approx. 5%, 6.5%, 8%, 12%).
Correlation (Method Comparison) Study:
- Study Type: Method comparison study developed with reference to CLSI protocol EP9-A2-IR.
- Sample Size: 120 unaltered EDTA whole blood specimens (frozen).
- Data Source: Analyzed on the Automated Glycohemoglobin Analyzer HLC-723G8 (candidate method) and Primus ultra2 (comparative method) by a secondary NGSP reference laboratory.
- Key Results:
- Regression Analysis (Deming): Slope = 0.996 (0.971 to 1.021), Intercept = 0.073 (-0.110 to 0.255), Correlation Coefficient (R) = 0.991, Bias = 0.047 (0.657 %).
- Result Ranges: 4.50% to 16.5%.
- Total Error Near the Cutoff: %TE values were ≤6% for all four concentrations tested (5.0%, 6.5%, 8.0%, 12.0%). (TE)95 values were within the goal at 6% for all tested decision levels.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Precision:
- Within-run Precision (Intra-assay) Coefficient of Variation: 0.18% to 1.00%
- Total Precision Coefficient of Variation: 0.68% to 1.83%
- Correlation Coefficient (R): 0.991
- Bias (from method comparison): 0.047 (0.657 %)
- Total Error (%TE): ≤6% (acceptable)
- (TE)95: Ranged from 0.13 to 0.34, within the goal at 6% (0.30 to 0.72)
Predicate Device(s)
K121291 Roche Diagnostics Corporation COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay
Reference Device(s)
Not Found
Pre-determined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.
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K13/570
510(k) Summary
JAN 2 3 2014
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Tosoh Bioscience, Inc.'s Automated Glycohemoglobin Analyzer HLC-723G8
Submitter:
Contact Person:
: : : :
Device Name: Classification Name:
Predicate Device:
Tosoh Bioscience, Inc 3600 Gantz Road Grove City, OH 43123
Robert L. Wick Regulatory Specialist 6000 Shoreline Ct., Ste. 101 South San Francisco, CA 94080 . Phone: 650-636-8117 Fax: 650-636-8121 : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Email: Robert.Wick@Tosoh.com
Automated Glycohemoglobin Analyzer HLC-723G8 Hemoglobin A1c Test System Class II PDJ 21 CFR 862.1373 : ・・・・・
K121291 Roche Diagnostics Corporation COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay
1
510(k) Summary
Automated Glycohemoglobin Analyzer HLC-723G8
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Device Description:
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports stable A 1c (sA1c) percentage in whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, floppy disk drive unit, operation panel and a printer.
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses non-porous ion- exchange high performance liquid chromatography (HPLC) for rapid, accurate and precise separation of the stable form of HbA Ic from other hemoglobin fractions. The G8 uses a cation exchange column and separates the usual hemoglobin components in the blood into six fractions, A 1a, A 1b, F, LA 1c, sA Ic, and A0. The separation is done by eluting the hemoglobins from the column with a stepwise elution of three elution buffers containing different salt concentrations. The result report includes a sample ID, date, percentage and retention time of each fraction, sA1c percentage and total A1 percentage (A1a + A1b + sA1c), along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the material depending upon its charge.
New Device Intended Use:
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin A Ic (HbA 1c) (DCCT/NGSP) and mmol/mo hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
2
Substantial Equivalence:
Comparison between the Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 and the COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay
Similarities
| Parameter | Tosoh Automated
Glycohemoglobin Analyzer
HLC-723G8 (k)071132
(k)131580 | COBAS INTEGRA 800
Tina-quant
HbA1cDx Gen.2 assay
(k)121291 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Tosoh Automated
Glycohemoglobin Analyzer
HLC-723G8 is intended for in
vitro diagnostic use for the
measurement of hemoglobin
A1c (HbA1c) in whole blood
specimens. Hemoglobin A1c
measurements are used in the
clinical management of
diabetes to assess the long-
term efficacy of diabetic
control. This test is to be used
as an aid in diagnosis of
diabetes and identifying
patients who may be at risk for
developing diabetes. | This test is to be used as an aid
in diagnosis of diabetes and as
an aid in identifying patients
who may be at risk for
developing diabetes The
COBAS INTEGRA 800 Tina-
quant HbA1cDx Gen.2 assay
is an in vitro diagnostics
reagent system intended for
quantitative determination of
mmol/mol hemoglobin A1c
(IFCC) and % hemoglobin
A1c (DCCT/NGSP) in
hemolysate or whole blood on
the Roche COBAS INTEGRA
800 clinical chemistry
analyzer |
| Specimen Type
Matrix | Human Whole Blood
EDTA Whole Blood | Human Whole Blood
EDTA, Li-Heparin, Na
Heparin, NaF/K- Oxalate |
| Standardization | Certified via the National
Glycohemoglobin
Standardization
Program (NGSP) | Certified via the National
Glycohemoglobin
Standardization
Program (NGSP) |
| Linearity | Linearity was previously
evaluated for this assay under
K071132. The reportable
range is 4.0% - 16.9%. | Linearity was previously
evaluated for this assay under
K072714. The reportable
range is 4.2-20.1% |
| Interference | Substances were evaluated at
two HbA1c levels (6.5% and
≥8% HbA1c)
Lipemia
Conjugated Bilirubin
Unconjugated bilirubin
Rheumatoid Factor
Glucose
Total Protein
Ascorbic Acid | Substances were evaluated at
two HbA1c levels (~6.5 and
~8.9% HbA1c)
Lipemia
Conjugated Bilirubin
Unconjugated bilirubin
Rheumatoid Factor
Glucose
Total Protein
Ascorbic Acid |
| | Acetaldehyde | |
| Precision | HbA1c concentration values of
approximately 5%, 6.5%, 8%
and 12% | HbA1c concentration values of
approximately 5%, 6.5%, 8%
and 10% |
| | Precision was determined to
be 0.7 - 1.8% (total precision)
and 0.3 - 0.9% (within run,
precision). | The between-analyzer and
between-lot precision was
equal to or less than 1.5% for
concentrations in the range of
5.3% to 12.1% HbA1c |
| Hemoglobin Variant
Interference | HbA2, HbS, HbC, HbD, does
not interfere with the assay. | HbA2, HbS, HbC, HbD, does
not interfere with the assay. |
| Bias | Concentration and Bias: | Concentration and Bias: |
| | 6.0% -0.847% | 5.2% 1.21% |
| | 6.5% -0.753% | 6.5% 1.29% |
| | 7.0% -0.673% | 8.0% 1.34% |
| Total Error - allowable bias
6% | Concentration and Total Error | Concentration and Total Error |
| | 5.0 5.8% | 5.2 4.2% |
| | 6.5 2.8% | 6.5 4.1% |
| | 8.0 3.0% | 8.0 4.1% |
| | 12.0 3.1% | |
3
Differences
:
·
| Parameter | Tosoh Automated
Glycohemoglobin Analyzer
HLC-723G8 (k)071132 | COBAS INTEGRA 800
Tina-quant
HbA1cDx Gen.2 assay
(k)121291 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assay Principle | Ion-exchange HPLC | Quantitative turbidimetric
inhibition immunoassay |
| Detection Method | Visible wavelength detector | Absorption spectrum and
measured biochromatically. |
| Method Comparison | The method comparison study
was conducted utilizing the
Automated Glycohemoglobin
Analyzer HLC-723G8 and the
Primus model ultra2.
r = 0.991
(Y = 0.996x + 0.073) | The method comparison study
was conducted using utilizing
the Roche COBAS INTEGRA
800 Tina-quant HbA1cDx
Gen.2 assay and the Tosoh
Automated Glycohemoglobin
Analyzer HLC-723G8.
r = None Listed
(Y = 1.015x + 0.015) |
| | Hemoglobin Variant
Interference | HbE does interfere with the
assay. |
Automated Glycohemoglobin Analyzer HLC-723G8
4 of 10
.
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PERFORMANCE CHARACTERISTICS
Interference:
This interference study was developed according to the CLSI guideline Interference Testing in Clinical Chemistry (EP7-A2).
Interference studies were conducted on known concentrations of HbA l . They were spiked with increasing amounts of the substances below. Interference was determined as a variance greater than the assigned value x 1.00 ± 5%.
| Potential
Interferent | Range tested | %A1c
Concentrations | Concentration in which
no significant
interference was
observed |
|--------------------------|------------------|------------------------|--------------------------------------------------------------------------|
| Acetylated Hb | 10 - 50 mg/dL | 6.5 and 9.5 | 50 mg/dL |
| Albumin | 500 - 5000 mg/dL | 6.6 and 14.7 | 5000 mg/dL |
| Aldehyde Hb | 5.0 - 25 mg/dL | 6.3 and 12.6 | 25 mg/dL |
| Ascorbic Acid | 3.0 - 25 mg/dL | 6.4 and 10.8 | 25 mg/dL |
| Carbamylated Hb | 5.0 - 25 mg/dL | 6.5 and 9.8 | 25 mg/dL |
| Bilirubin C | 2.0 - 21 mg/dL | 6.5 and 14.3 | 21 mg/dL |
| Labile Hb | 200 – 1000 mg/dL | 6.4 and 10.3 | 1000 mg/dL |
| Lipemia | 100 - 1000 mg/dL | 6.4 and 14.1 | 1000 mg/dL |
| Rheumatoid Factor | 110 - 550 IU/mL | 6.3 and 12.6 | 550 IU/mL |
| Bilirubin F | 2.0 - 18 mg/dL | 6.5 and 14.3 | 18 mg/dL |
5
| Hemoglobin Variant Interference study | ||
|---|---|---|
| Hemoglobin
Variant | Number of
Samples at
approximately
6% and ≥8% | %
HbA1c
reference
values | IFCC
mmol/ml | % Variant | Interference |
|-----------------------|--------------------------------------------------------|-----------------------------------|-----------------|-----------|--------------|
| HbS | 10 | 6.2 | 44 | 36.42 | No |
| | 10 | 9.8 | 78.1 | 29.49 | No |
| HbC | 10 | 6.7 | 47 | 36.54 | No |
| | 10 | 8.0 | 59.4 | 35.06 | No |
| HbE* | 10 | 6.9 | N/A* | N/A* | Yes |
| | 10 | 9.8 | N/A* | N/A* | Yes |
| HbD | 10 | 6.0 | 43.1 | 36.23 | No |
| | 10 | 8.5 | 66.9 | 35.70 | No |
| HbF | 10 | 7.0 | 56.5 | 24.38 | No |
| | 10 | 8.7 | 74 | 7.43 | No |
| HbA2 | 10 | 6.59 | 47.1 | 13.9 | No |
| | 10 | 8.05 | 62.9 | 12.7 | No |
*The G8 has known HbE interference. When a sample is suspected to contain HbE, a flag will be displayed. The %HbA Ic result will not be reported from the analyzer.
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 has known Hemoglobin E (HbE) interference. When a sample is suspected to contain HbE a flag will be displayed. The HbA1c result will not be reported from the analyzer.
The percent relative bias from the reference method at low and high concentrations of %HbA I c in each sample is:
| Hb Variant | Percent Relative Bias from Reference Method
at Low and High Concentrations of %HbA1c
Samples | |
|------------|----------------------------------------------------------------------------------------------------|-----------|
| | ~6.5 %HbA1c | ≥8 %HbA1c |
| S | 0 | -5 |
| C | 5 | -5 |
| E | *Flag | *Flag |
| D | 1 | -3 |
| A2 | -2 | -2 |
| F | 5 | 2 |
Precision:
The precision study was developed with reference to the CLSI protocol entitled: Evaluation of Precision Performance of Quantitative Measurement Methods (EP5-A2).
6
Precision was assessed by assaying four concentrations of unaltered EDTA whole blood specimens with each using 3 lots and 3 instruments. Estimates of total and within-run precision were obtained from measurements of 2 replicates in a single run, 2 times a day for 20 nonconsecutive days for each specimen/reagent combination. This equaled a total of 40 runs and 80 determinants for each data set. There were three (3) data sets at HbA Ic concentrations of approximately 5%, 6.5%, 8% and 12% for each specimen.
Within-run Precision
Intra-assay (within run) Precision
| | Mean | Standard
Deviation | Coefficient of
Variation |
|--------------------------|-------|-----------------------|-----------------------------|
| Sample | (%) | (%) | (%) |
| EDTA Whole Blood 5% A1 | 4.98 | 0.04 | 0.86 |
| EDTA Whole Blood 5% A2 | 5.00 | 0.05 | 1.00 |
| EDTA Whole Blood 5% A3 | 4.93 | 0.03 | 0.68 |
| EDTA Whole Blood 6.5% B1 | 6.50 | 0.02 | 0.29 |
| EDTA Whole Blood 6.5% B2 | 6.51 | 0.02 | 0.35 |
| EDTA Whole Blood 6.5% B3 | 6.44 | 0.03 | 0.44 |
| EDTA Whole Blood 8% C1 | 7.89 | 0.02 | 0.26 |
| EDTA Whole Blood 8% C2 | 7.90 | 0.03 | 0.32 |
| EDTA Whole Blood 8% C3 | 7.81 | 0.03 | 0.34 |
| EDTA Whole Blood 12% D1 | 11.90 | 0.02 | 0.18 |
| EDTA Whole Blood 12% D2 | 11.89 | 0.03 | 0.23 |
| EDTA Whole Blood 12% D3 | 11.79 | 0.03 | 0.27 |
Total Precision
.
.
| | Mean | Standard
Deviation | Coefficient of
Variation |
|--------------------------|-------|-----------------------|-----------------------------|
| Sample | (%) | (%) | (%) |
| EDTA Whole Blood 5% A1 | 4.98 | 0.09 | 1.83 |
| EDTA Whole Blood 5% A2 | 5.00 | 0.09 | 1.79 |
| EDTA Whole Blood 5% A3 | 4.93 | 0.08 | 1.69 |
| EDTA Whole Blood 6.5% B1 | 6.50 | 0.04 | 0.68 |
| EDTA Whole Blood 6.5% B2 | 6.51 | 0.07 | 1.14 |
| EDTA Whole Blood 6.5% B3 | 6.44 | 0.07 | 1.10 |
| EDTA Whole Blood 8% C1 | 7.89 | 0.08 | 0.98 |
| EDTA Whole Blood 8% C2 | 7.90 | 0.07 | 0.89 |
| EDTA Whole Blood 8% C3 | 7.81 | 0.07 | 0.86 |
| EDTA Whole Blood 12% D1 | 11.90 | 0.16 | 1.31 |
| EDTA Whole Blood 12% D2 | 11.89 | 0.19 | 1.58 |
| EDTA Whole Blood 12% D3 | 11.79 | 0.13 | 1.14 |
7
Correlation:
The methods comparison study was conducted with reference to the CLSI protocol entitled: Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline (EP9-A2-IR).
Comparative testing was conducted between samples which were analyzed on the Automated Glycohemoglobin Analyzer HLC-723G8 (candidate method) and Primus ultra2 (comparative method) analyzed by a secondary NGSP reference laboratory.
A total of 120 unaltered EDTA whole blood specimens were assayed in singleton. Frozen specimens were utilized for this study. The sample distribution is as follows:
| Hemoglobin A1c level | Number of samples
tested at each A1c
Level | %samples tested |
|----------------------|--------------------------------------------------|-----------------|
| ≤ 5% | 5 | 4.2% |
| 5 – 6% | 15 | 12.5% |
| 6 – 6.5% | 30 | 25.0% |
| 6.5 – 7% | 30 | 25.0% |
| 7 – 8% | 20 | 16.7% |
| 8 – 9% | 10 | 8.3 |
| > 9% | 10 | 8.3% |
| Total samples | 120 | 100% |
| Regression Analysis | ||
|---|---|---|
| Deming | Regular | |
| Slope: | 0.996 (0.971 to 1.021) | 0.987 (0.962 to 1.012) |
| Intercept: | 0.073 (-0.110 to 0.255) | 0.139 (-0.043 to 0.321) |
| Corr Coef (R): | 0.991 | |
| Bias: | 0.047 (0.657 %) | |
| Points | ||
| (Plotted/Total): | 120/120 | |
| Result Ranges: | 4.50% to 16.5% |
Total Error Near the Cutoff
Using the results of bias estimation (%Bias) in the method comparison study and precision estimates in the precision study, Total Error (TE) at four concentrations: (5.0%, 6.5%, 8.0% and 12.0) was calculated as follows: %TE =|%Bias| + 1.96 %CV(1+%Bias). The results are presented in the tables below. %TE of ≤6% is acceptable.
| Decision Level % | % Bias | 1%CV | %TE |
|---|---|---|---|
| 1.08 | 0 . | ||
| 1.04 | W.V | ||
| ﻟﻠﺘﻌﻠﻴﻘﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ | 0 75 | ||
| N.I. | 0.68 | data o O |
8
| 8.0 | 0.54 | 0.98 | 3.0 |
|---|---|---|---|
| 12.0 | 0.24 | 1.31 | 3.1 |
Using the calculation: (TE)95 = Bias + 1.96*SD the results are shown in the following table:
| Decision Level % | Bias | SD | (TE)95 | Goal at 6% |
|---|---|---|---|---|
| 5.0 | 0.054 | 0.09 | 0.23 | 0.30 |
| 6.5 | 0.049 | 0.04 | 0.13 | 0.39 |
| 8.0 | 0.043 | 0.08 | 0.20 | 0.48 |
| 12.0 | 0.029 | 0.16 | 0.34 | 0.72 |
Image /page/8/Figure/4 description: This image is a scatter plot with the title "Scatter Plot". The x-axis is labeled "Ultra 2 (%)" and ranges from 5 to 15. The y-axis is labeled "G8 (%)" and ranges from 5 to 15. The plot shows a cluster of points that follow a linear trend, along with a legend indicating "Deming Regr", "1:1 Line", and "Med Dec Pt".
Standards:
| Number | FDA
Recognition
Number | Revision
Date | Title |
|----------------|------------------------------|------------------|-------------------------------------------------------------------------------------------------------------------|
| EP5-A2 | 7-110 | 10/31/2005 | Evaluation of Precision Performance of
Quantitative Measurement Methods: Approved
Guideline- Second Edition |
| EP09-A2-
IR | 7-92 | 03/08/2004 | Method Comparison and Bias Estimation Using
Patient Samples; Approved Guideline-Second
Edition |
| EP7-A2 | 7-127 | 05/21/2007 | Interference Testing in Clinical Chemistry;
Approved Guideline - Second Edition |
9
Linearity and Detection Limit:
Linearity was previously established for this assay under K071132. The reportable range for this device is 4.0-16.9% HbAlc.
Calibrator and Controls:
Calibrators (Tosoh A 1c Calibrator Set) and Controls (Canterbury Scientific Hemoglobin A 1c) are recommended for use with this device. The calibrators and controls were previously cleared under 510(k) numbers K071132 and K021484 respectively.
Traceability
The assigned HbA1c values of the Tosoh Automated Glycohemoglobin Analyzer are certified with The National Glycohemoglobin Standardization Program (NGSP). The NGSP certification expires in one year. See NGSP website for current certification at http://www.ngsp.org.
· The final reportable result is traceable to both the International Federation if Clinical Chemistry (IFCC) and the Diabetes Control and Complications Trial (DCCT). The International Federation of Clinical Chemistry (IFCC) units of mmol/mol are calculated using the Master Equation NGSP (%) =0.09148 x IFCC (mmol/mol) + 2.52. HbA 1c results are provided to the customers using two different units: NGSP equivalent units (%) and IFCC equivalent units (mmol/mol).
Conclusion:
The Tosoh Bioscience, Inc. Automated Glycohemoglobin Analyzer HLC-723G8 is substantially equivalent to the Roche Diagnostics Corporation, COBAS INTEGRA 800 Tina-quant HbA 1cDx Gen.2 assay (K121291) for in vitro diagnostic use for the measurement of hemoglobin Alc (HbA1c) in whole blood specimens and to be used as an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 23, 2014
TOSOH BIOSCIENCE. INC. C/O ROBERT WICK 6000 SHORELINE COURT SUITE 101 SOUTH SAN FRANCISCO CA 94080
Re: K131580
Trade/Device Name: Automated Glycohemoglobin Analyzer HLC-723G8 Regulation Number: 21 CFR 862.1373 Regulation Name: Hemoglobin A1c Test System Regulatory Class: II Product Code: PDJ Dated: December 20, 2013 Received: December 20, 2013
Dear Mr. Wick:
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 Parts 801 and 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 Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Wick
if you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/defiult.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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H.Lias-S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K131580
Device Name
Automated Glycohemoglobin Analyzer HLC-723G8
Indications for Use (Describe)
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quantitative measurement of % hemoglobin Alc (HbA Ic) (DCCT/NGSP) and mmol/mo hemoglobin A Ic (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY ....
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Stayce Beck
FORM FDA 3881 (1/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
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