(182 days)
Not Found
No
The summary describes a standard automated clinical chemistry analyzer and reagents. There is no mention of AI or ML in the intended use, device description, or performance studies. The automated monitoring of reagents and processes is a typical feature of such devices and does not necessarily imply AI/ML.
No.
This device is an in vitro diagnostic (IVD) device used for the quantitative determination of hemoglobin A1c and glucose, which are measurements used in the diagnosis and monitoring of diseases, not for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the measurement of glucose by this device "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 term "diagnosis" directly indicates a diagnostic function.
No
The device description clearly outlines a physical analyzer instrument with automated components, reagent handling, and a measurement disk, indicating it is a hardware device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the quantitative determination of HbA1c and glucose in whole blood samples. This is a key characteristic of in vitro diagnostics, as they analyze samples taken from the human body.
- Device Description: The description details a system that uses reagents to perform chemical reactions on the blood sample to obtain results. This process of analyzing biological samples outside of the body using reagents is the core of in vitro diagnostics.
- Purpose: The measurements are used for monitoring long-term glucose control in individuals with diabetes and for the diagnosis and treatment of carbohydrate metabolism disorders. These are clinical purposes achieved through the analysis of biological samples.
- Professional Use: While it's a point-of-care system, it's intended for professional use, which is common for IVDs used in clinical settings.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CFR, LCP
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 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).
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
Professional use, point-of-care
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical evaluations were performed for within-day imprecision, between-day imprecision, linearity, and interfering substances.
HbA1c:
- Within-day imprecision 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 evaluated in duplicate over 10 days ranged from 1.5 % CV to 3.0 % CV.
- Linearity studies demonstrated linearity throughout the reportable range.
- Interference testing showed no effect from high levels of glucose or bilirubin (conjugated or unconjugated).
Glucose:
- Within-day imprecision 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 evaluated in duplicate over 10 days, ranged 0.7 % CV to 1.1 % CV.
- Linearity studies demonstrated linearity throughout the reportable range.
- Interference testing showed no effect from high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, heparin sodium, or sodium fluoridc.
Clinical Data:
- The method comparison study shows substantial equivalence to FDA cleared comparison methods for HbA1c and Glucose.
- 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.
Conclusion: Non-clinical and clinical testing showed the test system to be safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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.
0
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
1
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 and | |
| APOLOWAKO Glucose are for the | ||
| quantitative determination of | ||
| hemoglobin A1c (HbA1c) % and | ||
| glucose in whole blood samples. | "The Cholestech GDX A1C | |
| Test...is indicated for monitoring | ||
| the average blood glucose levels of | ||
| people with diabetes as an indicator | ||
| of overall blood glucose control." | ||
| "...for the quantitative | ||
| determination of glucose in whole | ||
| blood." | ||
| Indications for Use | ||
| From CFR 864.7470 and CFR | ||
| 862.1345 | Measurement of glycosylated | |
| hemoglobin is used to assess the | ||
| level of control of a patient's | ||
| diabetes and to determine the | ||
| proper insulin dosage for a patient. | Measurement of glycosylated | |
| hemoglobin is used to assess the | ||
| level of control of a patient's | ||
| diabetes and to determine the | ||
| proper 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
2
| | Elevated levels of glycosylated
hemoglobin indicate uncontrolled
diabetes in a patient. | Elevated levels of glycosylated
hemoglobin indicate uncontrolled
diabetes in a patient. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Measurement of glucose is used in
the diagnosis and treatment of
carbohydrate metabolism disorders,
including diabetes mellitus,
neonatal hypoglycemia and
idiopathic hypoglycemia. | Measurement of glucose is used in
the diagnosis and treatment of
carbohydrate metabolism disorders,
including diabetes mellitus,
neonatal hypoglycemia and
idiopathic hypoglycemia. |
| Sample | Whole blood | Whole blood |
| Sample Preparation | Venous whole blood sample | Finger stick or venous whole blood
sample |
| Calibration | Calibration is required at the time
the reagent is opened and lasts for
28 days or until expiration date. | No calibration is performed by the
user. |
| Methodology | Colorimetric, enzyme-based
(glucose); absorbance, immune
inhibition (HbA1c) | Colorimetric, affinity
chromatography |
| Testing Environment | Professional use, point-of-care | Prescription home use (A1c)
Professional use, point-of-care
(glucose) |
3
| Reportable
range | HbA1c: 3-16.5%
Glucose: 18-350 mg/dL | HbA1c: 4-15%
Glucose: 50-500 mg/dL |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | HbA1c: Total imprecision is 3% or
less across a range of 4.8% to
15.2% (mean values).
Glucose: Total imprecision is less
than 2% CV across a range of 72
mg/dL to 540 mg/dL (mean
values). | HbA1c: Total imprecision less
than 4% across a range of 5.7% to
9.4% (mean values).
Glucose: Total imprecision less
than 6.5% across a range of 103
mg/dL to 127 mg/dL. |
| Linearity | Assay linear throughout reportable
range | Assay linear throughout reportable
range |
| Interfering
Substances | 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. | For HbA1c: No interference was
seen from high levels of bilirubin,
acetylsalicylic acid, caffeine,
acetaminophen, and hydroxyzine
dihydroxychloride. Elevated lipid
may interfere and cause low results
in this type of assay.
For glucose: There may be a 6-7%
difference in the glucose levels of
fingerstick and venous blood. (23
other 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
4
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.
5
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).
6
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
7
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