(182 days)
The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.
Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
The Wako Diagnostics APOLOWAKO HbA1c and APOLOWAKO Glucose test systems were evaluated for their ability to quantitatively determine hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Predicate Device) | APOLOWAKO HbA1c Performance | APOLOWAKO Glucose Performance |
|---|---|---|---|
| Intended Use | Quantitative determination of HbA1c and glucose in whole blood for monitoring diabetes and diagnosing carbohydrate metabolism disorders. | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). | Quantitative determination of HbA1c and glucose in whole blood samples for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for diagnosis/treatment of carbohydrate metabolism disorders (Glucose). |
| Reportable Range | HbA1c: 4-15% Glucose: 50-500 mg/dL | HbA1c: 3-16.5% | Glucose: 18-350 mg/dL |
| Precision (Total Imprecision) | HbA1c: < 4% across 5.7%-9.4% (mean values) Glucose: < 6.5% across 103-127 mg/dL (mean values) | HbA1c: 3% or less across 4.8%-15.2% (mean values) | Glucose: Less than 2% CV across 72-540 mg/dL (mean values) |
| Linearity | Assay linear throughout reportable range | Assay linear throughout reportable range | Assay linear throughout reportable range |
| Interfering Substances | HbA1c: No interference from bilirubin, acetylsalicylic acid, caffeine, acetaminophen, hydroxyzine dihydroxychloride; elevated lipids may interfere. Glucose: Possible 6-7% difference between fingerstick and venous blood; 23 other substances had no effect. | No interference from high levels of bilirubin (conjugated and unconjugated), triglycerides, hemoglobin (for glucose only), sodium fluoride (glucose only), heparin sodium, EDTA-2Na, ascorbic acid, and others. Labile HbA1c, carbamylated hemoglobin, or acetylated hemoglobin has no influence on the HbA1c assay. | No interference from high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, heparin sodium, or sodium fluoride. |
Study that Proves Device Meets Acceptance Criteria:
The device's performance was evaluated through a combination of non-clinical and clinical studies.
2. Sample Size Used for the Test Set and Data Provenance
- HbA1c Test Set Sample Size: At least 352 samples.
- Glucose Test Set Sample Size: At least 387 samples.
- Data Provenance: Not explicitly stated, but the submission is from Wako Diagnostics, a US-based company, suggesting the studies were conducted to meet US regulatory requirements. The mention of "rigorous conditions sufficient to meet the requirements for CLIA Waiver" implies a focus on a US clinical laboratory context. The data is retrospective, derived from already collected samples used for method comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the test set was established by "FDA cleared comparison methods" and "reference method" as per the method comparison study, not by expert review of individual cases.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by comparison to reference methods, not by human expert adjudication of individual results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The evaluation focused on the accuracy of the device's measurements compared to predicate and reference methods, not on human reader performance with or without AI assistance.
6. Standalone Performance
Yes, a standalone performance study was done. The non-clinical evaluations (imprecision, linearity, interfering substances) and the method comparison study directly assess the algorithm's (device's) performance without human intervention in the result generation process. The device itself is described as an "analyzer" that performs "up to six analytical tests per individual sample" and "automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement
process to ensure that no erroneous results are shown," indicating standalone operation.
7. Type of Ground Truth Used
The ground truth used for the method comparison study was established by "FDA cleared comparison methods" and "reference method." This typically implies standardized laboratory assays or methods previously validated and cleared by regulatory bodies, representing the clinical standard for measuring HbA1c and glucose.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. In the context of in-vitro diagnostic devices like this one, development and internal validation (which might involve training if machine learning was used, though not explicitly stated for this 2008 device) would precede the reported verification and validation studies. The numbers provided (352 for HbA1c, 387 for glucose) are for the clinical method comparison study, which serves as a validation set.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned, information on how its ground truth was established is not available in the provided text. For devices of this nature, ground truth for development and internal validation would typically be established using highly accurate laboratory reference methods or certified reference materials.
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KOSO123
Wako Diagnostics Wako
JUL 1 7 2008
SECTION 9
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K080123.
807.92 (a)(1): Namc: Wako Diagnostics Address: 665 Clyde Avenue, Suite B Mountain View, CA 94043 Phone: (650) 210-9153 FAX: (650) 210-9170 Contact: Peter Panfili, Ph.D.
807.92 (a)(2): Device name- trade name and common name, and classification
Trade Name:
APOLOWAKO HbA1c and APOLOWAKO GLU
Common Name:
Test system for individual reporting of:
- HbAlc -
- ﺖ Glucose
Classification:
Glycosylated hemoglobin assay, Section 864.7470, Class II Glucose Test System, Section 862.1345, Class II
807.92 (a)(3): Identification of the legally marketed predicate device
CHOLESTECH LDX and CHOLESTECH GDX, Cholestech Corporation, Hayward, CA cleared under K904082 (LDX), K904082 (Glucose) and K011933 (GDX).
807.92 (a)(4): Device Description
The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer
Wako Chemicals USA, Inc. · 1600 Bellwood Drive · Richmond · VA · 23237 Email: liver@wakousa.com · Phone: 877-714-1924 · Fax: 804-271-0449 Website: www.wakodiagnostics.com
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automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).
807.92 (a)(5): Intended Use
The APOLOWAKO HbA1c and APOLOWAKO Glucosc are for the quantitative determination of hemoglobin Alc (HbAlc) % and glucose in whole blood samples.
807.92 (a)(6): Technological Similarities and Differences to the Predicate
| CHARACTERISTIC | APOLOWAKO Analyzer | Cholestech LDX & GDX Systems |
|---|---|---|
| Intended Use | The APOLOWAKO HbA1c andAPOLOWAKO Glucose are for thequantitative determination ofhemoglobin A1c (HbA1c) % andglucose in whole blood samples. | "The Cholestech GDX A1CTest...is indicated for monitoringthe average blood glucose levels ofpeople with diabetes as an indicatorof overall blood glucose control.""...for the quantitativedetermination of glucose in wholeblood." |
| Indications for UseFrom CFR 864.7470 and CFR862.1345 | Measurement of glycosylatedhemoglobin is used to assess thelevel of control of a patient'sdiabetes and to determine theproper insulin dosage for a patient. | Measurement of glycosylatedhemoglobin is used to assess thelevel of control of a patient'sdiabetes and to determine theproper insulin dosage for a patient. |
Similarities / Differences between the APOLOWAKO HbA1c, APOLOWAKO Glucose and Established Predicate Devices (Cholestech LDX and GDX)
Wako Chemicals USA, Inc. · 1600 Bellwood Drive · Richmond · VA · 23237 Email: liver@wakousa.com · Phone: 877-714-1924 · Fax: 804-271-0449 Website: www.wakodiagnostics.com
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| Elevated levels of glycosylatedhemoglobin indicate uncontrolleddiabetes in a patient. | Elevated levels of glycosylatedhemoglobin indicate uncontrolleddiabetes in a patient. | |
|---|---|---|
| Measurement of glucose is used inthe diagnosis and treatment ofcarbohydrate metabolism disorders,including diabetes mellitus,neonatal hypoglycemia andidiopathic hypoglycemia. | Measurement of glucose is used inthe diagnosis and treatment ofcarbohydrate metabolism disorders,including diabetes mellitus,neonatal hypoglycemia andidiopathic hypoglycemia. | |
| Sample | Whole blood | Whole blood |
| Sample Preparation | Venous whole blood sample | Finger stick or venous whole bloodsample |
| Calibration | Calibration is required at the timethe reagent is opened and lasts for28 days or until expiration date. | No calibration is performed by theuser. |
| Methodology | Colorimetric, enzyme-based(glucose); absorbance, immuneinhibition (HbA1c) | Colorimetric, affinitychromatography |
| Testing Environment | Professional use, point-of-care | Prescription home use (A1c)Professional use, point-of-care(glucose) |
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| Reportablerange | HbA1c: 3-16.5%Glucose: 18-350 mg/dL | HbA1c: 4-15%Glucose: 50-500 mg/dL |
|---|---|---|
| Precision | HbA1c: Total imprecision is 3% orless across a range of 4.8% to15.2% (mean values).Glucose: Total imprecision is lessthan 2% CV across a range of 72mg/dL to 540 mg/dL (meanvalues). | HbA1c: Total imprecision lessthan 4% across a range of 5.7% to9.4% (mean values).Glucose: Total imprecision lessthan 6.5% across a range of 103mg/dL to 127 mg/dL. |
| Linearity | Assay linear throughout reportablerange | Assay linear throughout reportablerange |
| InterferingSubstances | No interference from high levels ofbilirubin (conjugated andunconjugated), triglycerides,hemoglobin (for glucose only),sodium fluoride, (glucose only),heparin sodium, EDTA-2Na,ascorbic acid and others. LabileHbA1c, carbamylated hemoglobinor acetylated hemoglobin has noinfluence on the HbA1c assay. | For HbA1c: No interference wasseen from high levels of bilirubin,acetylsalicylic acid, caffeine,acetaminophen, and hydroxyzinedihydroxychloride. Elevated lipidmay interfere and cause low resultsin this type of assay.For glucose: There may be a 6-7%difference in the glucose levels offingerstick and venous blood. (23other substances had no effect). |
807.92 (b)(1): Brief Description of Non-clinical Data
Evaluations were performed for within-day imprecision, between-day imprecision, linearity, and interfering substances. Those resulting data are summarized below.
HbA1c
Within-day imprecision, when evaluated at three levels of hemoglobin (low- 4.8 %, intermediate- 7.7 %, and high- 16.7 %), ranged from 1.2 % CV to 1.5 % CV. Between-day imprecision, when evaluated in duplicate over 10 days ranged from1.5 % CV to 3.0 % CV.
Results from linearity studies demonstrated that the hemoglobin A1c ratio (%) is linear throughout the reportable range.
Results from an interference testing showed hemoglobin A1c assay is not affected by high levels of glucose or bilirubin (conjugated or unconjugated).
Wako Chemicals USA, Inc. · 1600 Bellwood Drive · Richmond · VA · 23237 Email: liver@wakousa.com · Phone: 877-714-1924 · Fax: 804-271-0449 Website: www.wakodiagnostics.com
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Glucose
Within-day imprecision, when evaluated at three levels of glucose (low-56 mg/dL, intermediate- 97 mg/dL, and high- 588 mg/dL), ranged from 0.6 % CV to 1.8 % CV. Between-day imprecision. when evaluated with in duplicate over 10 days, ranged 0.7 % CV to 1.1 % CV.
Results from linearity studies demonstrated that the glucose is linear throughout the reportable range.
Results from an interference testing showed that the glucose is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, heparin sodium, or sodium fluoridc.
807.92 (b)(2): Brief Description of Clinical Data
The method comparison study shows substantial equivalence to FDA cleared comparison methods for HbAlc and Glucosc. For each analyte at least 387 (352 for HbA1c) broadly distributed samples showed statistically significant correlation to the reference method with slopes approaching 1.0 and y-intercepts approaching zero. APOLOWAKO results were collected under rigorous conditions sufficient to meet the requirements for CLIA Waiver. The results show correlation coefficients of 0.99 or better for each assay.
807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing
Non-clinical and clinical testing was performed for the APOLOWAKO HbAlc and APOLOWAKO Glucose. The test system was shown to be safe and effective for its intended use.
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, facing to the left.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Wako Chemicals USA, Inc. c/o Mr. Peter Panfili 665 Clyde Avenue, Suite B Mountain View, CA 94043
'JUL 1 7 2008
Re: K080123
Trade/Device Name: APOLOWAKO Glu and APOLOWAKO HbA1c Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR and LCP Dated: June 24, 2008 Received: June 30, 2008
Dear Mr. Panfili:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet audiess at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K080123
Device Name: The APOLOWAKO HbA1c and APOLOWAKO GLU
Intended Use
The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.
Indications for Use
HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.
Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.
Prescription Use X (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
And/Or
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Carol C. Benson
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K08012-3
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.