(90 days)
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.
The G7 Automated HPLC Analyzer - Beta-thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. A chromatographic tracing of the hemoglobin products found in the sample is also produced which allows for the comparison of an individual chromatogram with standard patterns of known composition. The operational portion of the G7 Beta-thalassemia Mode is composed of a sampling unit, liquid pump, degasser, detector, microprocessors, sample loader, floppy disk drive unit, operational panel and a printer all of which have already been cleared by the FDA (K011434). The reagents and software program specific to the Beta-thalassemia Mode consist of calibrators, elution buffers, column and software only.
The G7 Automated HPLC System - Beta-thalassemia Mode uses a cation exchange column and separates the hemoglobin in the blood into fractions. The separation is accomplished by eluting the hemoglobins from the column with a gradient of three elution buffers containing increasing salt concentrations. The resulting report is printed out on the on-board printer and can be stored on a floppy disk in the on-board floppy disk drive. The data can also be transmitted to a host computer through the RS232 port. The result report includes a sample ID, date, time, area percentages and retention time in minutes of each individual peak detected. Peaks that meet the retention time "windows" pre-set in the software are labeled as F, A0, A2, D+, S+, C+. All others are designated in order of appearance as PXX and are listed in order of appearance.
All automated processes in the G7 Beta-thalassemia Mode are controlled by internal microprocessors using software downloaded via the on-board floppy disk drive.
The Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for in vitro diagnostic use for the separation and area percent determinations of hemoglobins A2 and F, and as an aid in detecting and presumptively identifying abnormal hemoglobins in whole blood using ion-exchange high-performance liquid chromatography (HPLC).
Here’s a breakdown of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the comparison to predicate devices, where the device's performance (correlation, imprecision) should be comparable to or better than the predicate.
| Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Tosoh G7 Beta-thalassemia Mode) |
|---|---|
| Quantitative HbA2 Performance | |
| Correlation with Helena Beta-Thal HbA2 Quik Column™ (Predicate) | Slope: 0.9318, Y-Intercept: -1.08, Correlation Coefficient: 0.9318 |
| HbA2 Imprecision (CV%) | 1.3 - 2.1% (intra-assay); 2.4 - 3.3% (between day) |
| HbA2 Upper Linearity Limit | Up to 12.8 % |
| Quantitative HbF Performance | |
| Correlation with Bio-Rad VARIANT BETA-THALASSEMIA SHORT PROGRAM (Predicate) | Slope: 0.778, Y-Intercept: 1.15, Correlation Coefficient: 0.9906 |
| HbF Imprecision (CV%) | 4.3 - 13.5% (intra-assay); 2.2 - 7.7% (between day) |
| HbF Upper Linearity (Reportable) | Up to 35.0 % |
| Qualitative Hemoglobin Identification Performance | |
| Agreement with Beckman Paragon® Hemoglobin Electrophoresis (Predicate) | 100% agreement between G7 Presumptive Result and Electrophoresis Result for the specific categories reported in the comparative analysis table (e.g. HbA/HbS*, HbA/HbC*). |
2. Sample Sizes Used for the Test Set and Data Provenance
- Quantitative HbA2 Test Set:
- Sample Size: 75 patient specimens.
- Data Provenance: Not explicitly stated, but "Patient specimens were analyzed" suggests clinical samples. The type of study (retrospective/prospective) is not specified, but typically, these comparative studies are conducted prospectively or using archived clinical samples.
- Quantitative HbF Test Set:
- Sample Size: 57 patient specimens.
- Data Provenance: Not explicitly stated, but "Patient specimens were analyzed" suggests clinical samples. The type of study is not specified.
- Qualitative Hemoglobin Identification Test Set:
- Sample Size: 155 total comparisons (patient whole blood samples).
- Data Provenance: Whole blood from patients "suspected of having hemoglobinopathies" were tested. This suggests clinical samples with a range of conditions. The type of study is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was not established by human experts in the traditional sense. Instead, it was established by predicate devices that are already commercially available and considered legally marketed for their respective intended uses.
- For quantitative HbA2, the predicate device was Helena Laboratories' Beta-Thal HbA2 Quik Column™.
- For quantitative HbF, the predicate device was Bio-Rad Laboratories VARIANT™ BETA-THALASSEMIA SHORT PROGRAM.
- For qualitative hemoglobin identification, the predicate device was Beckman Paragon® Hemoglobin Electrophoresis.
4. Adjudication Method for the Test Set
There was no human "adjudication method" in the context of resolving disagreements between multiple human readers. The comparison was directly between the Tosoh G7 device and the predicate laboratory devices. The "ground truth" for each sample was implicitly determined by the result from the predicate device (or in the case of qualitative identification, agreement with the predicate result).
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
No MRMC comparative effectiveness study was done. This device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic tool designed to improve human reader performance. The study focuses on the device's analytical performance compared to established laboratory methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The G7 Automated HPLC Analyzer: Beta-thalassemia Mode operated as an algorithm-only device (i.e., automated instrument) to process samples and generate results, which were then compared against established predicate devices. There is no human interaction described as part of its performance in these studies, only in the interpretation of its results.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the performance studies was based on results obtained from legally marketed predicate laboratory devices. These predicate devices represent established and accepted methods for measuring HbA2, HbF, and identifying abnormal hemoglobins.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" for the device's software or analytical methods. This is a traditional in vitro diagnostic device, not a machine learning or AI algorithm that typically goes through a distinct training phase with a labeled dataset. The instrument and its software, including elution protocols and peak "windows," are developed and validated by the manufacturer internally, but a dedicated "training set" in the AI sense is not usually disclosed or relevant for such devices in an FDA submission of this nature.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of, for example, a machine learning model is not applicable here. The ground truth for the development and internal validation of the instrument's operational parameters (e.g., software "windows" for hemoglobin components) would have been established through extensive analytical testing by the manufacturer, likely using characterized samples and reference methods. However, the details of this internal development and validation are not part of this 510(k) summary, which focuses on the comparative study for substantial equivalence.
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1020489
MAY 1 4 2002
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510(k) Summary
Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode
| Submitter: | Tosoh Medics, Inc.347 Oyster Point Blvd., Suite 201South San Francisco, CA 94080Phone: (800) 248-6764Fax: (610) 615-4970 |
|---|---|
| Contact Person: | Lois NakayamaManager, Quality Assurance |
| Date of Summary Preparation: | February 8, 2002 |
| Device Name: | G7 Automated HPLC Analyzer: Beta-thalassemia Mode |
| Classification Name: | Class II, JPD21 CFR 864.7400Hemoglobin A2 quantitation |
| Predicate Device: | HbA2: Beta-Thal HbA2 Quik ColumnTMHelena LaboratoriesBeaumont, TXK823870 |
| HbF: VARIANT BETA-THALASSEMIASHORT PROGRAMBio-Rad LaboratoriesHercules, CAK924122 | |
| Presumptive Hb identification:Beckman Paragon® ElectrophoresisBeckman Instruments, Inc.Fullerton, CAK802821 |
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Device Description:
The G7 Automated HPLC Analyzer and the HbA1c Variant Analysis Mode reagent system and software have previously cleared by the Food and Drug Administration (K011434). The subject of this submission is merely the reagent system/software specific for the Beta-thalassemia Mode that is intended for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The G7 Automated HPLC Analyzer - Beta-thalassemia Mode is an automated High Performance Liquid Chromatography (HPLC) system that separates and reports HbF and HbA2 quantitative percentages in whole blood. A chromatographic tracing of the hemoglobin products found in the sample is also produced which allows for the comparison of an individual chromatogram with standard patterns of known composition. The operational portion of the G7 Beta-thalassemia Mode is composed of a sampling unit, liquid pump, degasser, detector, microprocessors, sample loader, floppy disk drive unit, operational panel and a printer all of which have already been cleared by the FDA (K011434). The reagents and software program specific to the Beta-thalassemia Mode consist of calibrators, elution buffers, column and software only.
The G7 Automated HPLC System - Beta-thalassemia Mode uses a cation exchange column and separates the hemoglobin in the blood into fractions. The separation is accomplished by eluting the hemoglobins from the column with a gradient of three elution buffers containing increasing salt concentrations. The resulting report is printed out on the on-board printer and can be stored on a floppy disk in the on-board floppy disk drive. The data can also be transmitted to a host computer through the RS232 port. The result report includes a sample ID, date, time, area percentages and retention time in minutes of each individual peak detected. Peaks that meet the retention time "windows" pre-set in the software are labeled as F, A0, A2, D+, S+, C+. All others are designated in order of appearance as PXX and are listed in order of appearance.
All automated processes in the G7 Beta-thalassemia Mode are controlled by internal microprocessors using software downloaded via the on-board floppy disk drive.
Statement of Intended Use:
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ion-exchange high performance liquid chromatography (HPLC).
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.
Substantial Equivalence:
Comparison Data
The Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode is substantially equivalent in intended use to instrument and reagent systems in commercial distribution
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that are used to quantitate Hemoglobin A2 and Hemoglobin F in whole blood and qualitatively identify clinically important abnormal human hemoglobins.
Specifically, the Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode is substantially equivalent to the Helena Laboratories, Inc. (Beaumont, TX) Beta-Thal HbA2 Quik Column™ (K823870) method for quantitating Hemoglobin A2 and is substantially equivalent to the Bio-Rad Laboratories (Hercules, CA) VARIANT™ BETA-THALASSEMIA SHORT PROGRAM for quantitatiing Hemoglobin F (K924122) and to the Beckman Paragon® Hemoglobin Electrophoresis as an aid in identifying broad presumptive classes of abnormal human hemoglobins. A summary comparison of the capabilities and specifications of these systems is provided below in Table 1, Table 2 and Table 3.
| Table 1 |
|---|
| Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode HbA |
| vs. |
| Helena Quik ColumnTM HbA2 |
| G7 Automated HPLCAnalyzer: Beta-thal Mode | Beta-Thal HbA2 QuikColumn™ | |
|---|---|---|
| Intended Use | Quantitative measurementof HbA2 in whole blood | Quantitative measurementof HbA2 in whole blood |
| Methodology | High Performance LiquidChromatography usingcation exchange | Micro-chromatographictechnique using anionexchange |
| Separation Method | Based on differences inelectrical charge betweencolumn material andhemogoblin molecule | Based on differences inelectrical charge betweencolumn material andhemoglobin molecules |
| Sample Type | EDTA whole blood | EDTA whole blood |
| Microprocessor Controlled | YES | NO |
| Automatic Sampling | YES | NO |
| Elution Method | Buffers with differing saltconcentrations causing anelution gradient | Buffers with differing saltconcentrations causing anelution gradient |
| End Point | Colorimetric measurementat 415 nm | Colorimetric measurementat 415 nm |
| Results | Quantitative HbA2 Area % | Quantitative HbA2 Area % |
| Normal Reference Interval | 1.7 - 2.9 % | 2.2 - 3.3 % |
| Imprecision | 2.4 - 3.3 % | 3.25 % |
| Upper Linearity Limit | Up to 12.8 % | Not given |
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Table 2 Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode HbF VS. Bio-Rad Laboratories VARIANT™ BETA-THALASSEMIA SHORT PROGRAM HbF
| G7 Automated HPLC Analyzer: Beta-thal Mode | VARIANT™ BETA-THALASSEMIA SHORT PROGRAM | |
|---|---|---|
| Intended Use | Quantitative measurement of HbF in whole blood | Quantitative measurement of HbF in whole blood |
| Methodology | High Performance Liquid Chromatography using cation exchange | High Performance Liquid Chromatography using cation exchange |
| Separation Method | Based on differences in electrical charge between column material and hemogoblin molecule | Based on differences in electrical charge between column material and hemoglobin molecules |
| Sample Type | EDTA whole blood | EDTA whole blood |
| Microprocessor Controlled | YES | YES |
| Automatic Sampling | YES | YES |
| Calibration | One Point Dual Analyte Calibration | One Point Dual Analyte Calibration |
| Automated Sample Pretreatment | YES | NO |
| Elution Method | Buffers with differing salt concentrations causing an elution gradient | Buffers with differing salt concentrations causing an elution gradient |
| End Point | Colorimetric measurement at 415 nm | Colorimetric measurement at 415 nm |
| Results | Quantitative HbF Area % | Quantitative HbF Area % |
| Normal Reference Interval | 0.5 - 1.9 | 2.2 - 7.7 % |
| Imprecision (Intra-assay) | 2.2 -7.7 % | Not given |
| Upper Linearity(Reportable) | Up to 35.0 % | Up to 40% |
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Table 3 Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode VS. Beckman Paragon® Hemoglobin Electrophoresis
| G7 Automated HPLCAnalyzer: Beta-thal Mode | HemoglobinElectrophoresis | |
|---|---|---|
| Intended Use | Aid in the identification ofabnormal humanhemoglobins | Electrophoretic separationof human hemoglobins toscreen for clinicallyimportant hemoglobinvariants |
| Methodology | High Performance LiquidChromatography usingcation exchange | Electrophoresis |
| Separation Method | Based on differences inelectrical charge betweencolumn material andhemoglobin molecule | Based on differences inelectrical charge betweenthe media and hemoglobinmolecules |
| Sample Type | EDTA whole blood | EDTA whole blood |
| Microprocessor Controlled | YES | NO |
| Automatic Sampling | YES | NO |
| Calibration | Software "windows" forvarious hemoglobincomponents are preset | Comparison of unknownwith samples of knowncontent |
| Automated SamplePretreatment | YES | NO |
| Elution Method | Buffers with differing saltconcentrations causing anelution gradient | Buffers with differing saltconcentrations causing anelution gradient |
| End Point | Colorimetric measurementat 415 nm | Densitometer quantitationor visual interpretation ofpatterns obtained |
| Results | Presumptive identificationof certain hemoglobinvariants as "A", "F", "S", "C",and "D" or "unknown" | Qualitative presumptiveidentification of hemoglobinvariants "A", "F", "S", "C" or"unknown" |
| Normal Reference Interval | Compared to "normal"pattern | Compared to "normal"pattern |
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Comparative Analysis
Comparative Analysis Quantitative HbA2
Patient specimens were analyzed using the Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode and another commercially available quantitative HbA2 assay utilizing a micro-chromatographic methodology (Helena Laboratories' Beta-Thal HbA2 Quik Column™. Approximately onehalf the samples had HbA2 within the normal reference interval. The remainder showed elevated results. The comparison yielded the following correlation statistics when the two methods were compared using linear regression analysis:
| Slope: | 0.9318 |
|---|---|
| Y-Intercept: | -1.08 |
| Correlation Coefficient: | 0.9318 |
| Range of Samples (%): | 1.6 – 7.4% |
| n: | 75 |
Comparative Analysis Quantitative HbF
Patient specimens were analyzed with the Tosoh G7 Automated HPLC Analyzer: Beta-thalassemia Mode and another commercially available quantitative HbF assay utilizing HPLC (Bio-Rad Laboratories VARIANT BETA-THALASSEMIA SHORT PROGRAM. The comparison yielded the following correlation statistics between these two methods.
| Slope: | 0.778 |
|---|---|
| Y-Intercept: | 1.15 |
| Correlation Coefficient: | 0.9906 |
| Range of Samples (%): | 0.5 – 67.6 |
| n: | 57 |
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Qualitative Comparison of Hemoglobins in Clinical Samples
Whole blood from patients suspected of having hemoglobinopathies were tested on the G7 Automated HPLC Analyzer: Beta-thalassemia Mode and the Beckman Laboratories Paragon® Hemoglobin Electrophoresis. Results from these qualitative comparisons are listed below.
| G7 Presumptive Result | Electrophoresis Result | Number of Analyses |
|---|---|---|
| HbA/HbS* | HbA/HbS* | 37 |
| HbA/HbS*/HbA2* | HbA/HbS*/HbA2* | 1 |
| HbF*/HbS* | HbF*/HbS* | 1 |
| HbS*/HbC* | HbS*/HbC* | 2 |
| HbA/HbC* | HbA/HbC* | 11 |
| HbA/HbC*/HbF* | HbA/HbC*/HbF* | 1 |
| HbA/HbS*/HbF* | HbA/HbS*/HbF* | 1 |
| HbA/HbD* | HbA/HbD* | 7 |
| HbA/HbD*/HbF* | HbA/HbD*/HbF* | 1 |
| HbA/Hb Unknown | HbA/HbE* | 5 |
| HbA/unknown coelutingwith HbA2* (47.2%) | HbA/unknown | 1 |
| HbA/HbF*/Unknown fast* | HbA/HbF*/Hb Barts* | 1 |
| HbA/Hb Unknown* | HbA/Hb unknown* | 1 |
| HbA/HbA2*/HbF* | HbA/HbA2*/HbF* | 3 |
| HbA/HbA2*/HbF | HbA/HbA2*/HbF | 9 |
| HbF*/HbA/HbA2 | HbF*/HbA/HbA2 | 7 |
| HbF*/HbA/HbA2* | HbF/HbA/HbA2* | 6 |
| HbA/Hb Unknown* | HbA/HbG* | 5 |
| Normal HbA/HbF/HbA2 | Normal HbA/HbF/HbA2 | 55 |
| TOTAL COMPARISONS | 155 |
Precision studies demonstrated intra-assay precision % CVs on HbF of 4.3 - 13.5% and on HbA2 from 1.3 - 2.1 %. Between day precision CV%s of2.2 -- 7.7% on HbF and on HbA2 2.4 -- 3.3 %. Recovery studies performed on HbF and HbA2 showed recoveries ranging from 99.4% - 107.1%.
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Conclusion:
Considering the excellent correlation between the Tosoh G7 Automated HPLC Analyzer: Betathalassemia Mode and the other predicate devices listed above, it can be concluded that the G7 Automated HPLC Analyzer: Beta-thalassemia Mode is substantially equivalent to the other predicate devices which have been 510(K) cleared. Based on the establishment of substantial equivalence, the safety and effectiveness of the Tosoh G7 Automated HPLC Analyzer: Betathalassemia Mode is confirmed.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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MAY 1 4 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lois Nakayama Manager, Ouality Assurance TOSOH Medics, Inc. 347 Oyster Point Boulevard, Suite 201 South San Francisco, California 94080
K020489 Re:
Trade/Device Name: G7 Automated HPLC Analyzer: Beta-thalassemia Mode Regulation Number: 21 CFR § 864.7400 Regulation Name: Hemoglobin A2 quantitation Regulatory Class: II Product Code: JPD Dated: April 29, 2002 Received: May 1, 2002
Dear Ms. Nakayama:
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 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); 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
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html".
Sincerely vours.
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PREMARKET NOTIFICATION
INDICATION FOR USE STATEMENT
G7 Automated HPLC Analyzer: Beta-thalassemia Mode
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode is intended for IN VITRO DIAGNOSTIC USE ONLY for the separation and area percent determinations of hemoglobins A2 and F and as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood using ionexchange high performance liquid chromatography (HPLC).
The G7 Automated HPLC Analyzer: Beta-thalassemia Mode reagents and software are intended only for use on the Tosoh G7 Automated HPLC Analyzer.
Josephine Bautista.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020489
§ 864.7400 Hemoglobin A
2 assay.(a)
Identification. A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).(b)
Classification. Class II (performance standards).