(329 days)
Not Found
No
The description focuses on the reagents, calibrators, controls, and the analytical method (colorimetric and turbidimetric assay) used on a standard clinical chemistry analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an in vitro diagnostic reagent used to measure HbA1c, which is a diagnostic tool for monitoring diabetes, not a therapeutic device that treats or prevents a disease.
Yes.
The "Intended Use / Indications for Use" section states that the device is "for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbAlc) in human whole blood" and that "Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control," clearly indicating its use in diagnosing or monitoring a medical condition.
No
The device description explicitly states it includes reagents, controls, and calibrators, which are physical components, not software. It is intended for use on a specific hardware analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states that the reagents, calibrators, and controls "are for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbAlc) in human whole blood". This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Device Description: The description further reinforces this by stating "The ABX PENTRA HbA1c WB is an in vitro diagnostic assay for the quantitative determination of Hemoglobin A1c in human whole blood".
- Clinical Management of Diabetes: The intended use also mentions that the measurements are used in the "clinical management of diabetes", which is a key application for IVD devices.
Therefore, based on the provided text, the ABX PENTRA HBAIc WB reagent with associated calibrators and controls is clearly an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ABX Pentra HbA1c WB reagent is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of HbA1c using whole blood and hemolysate. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
ABX PENTRA HBAIc WB reagent with associated calibrators and controls are for quantitative in vitro diagnostic determination of Hemoglobin A1c percentage (%HbAlc) in human whole blood based on a colorimetric and turbidimetric assay. It is intended for use on ABX PENTRA 400 Clinical Chemistry Analyzer
Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control.
The ABX PENTRA HbAIc WB Cal is a calibrator for use in the calibration of quantitative Horiba ABX PENTRA HbAIc WB method on Horiba ABX clinical chemistry analyzers.
The ABX PENTRA HbAlc WB Control is for use in quality control by monitoring accuracy and precision for the quantitative ABX PENTRA HbA1c WB method.
The ABX PENTRA HbA1c WB Hemolysis Reagent is an additional reagent for use in combination for the quantitative ABX PENTRA HbA1c WB method.
Product codes (comma separated list FDA assigned to the subject device)
LCP, JIX, JJY
Device Description
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA HbA1c WB is an in vitro diagnostic assay for the quantitative determination of Hemoglobin A1c in human whole blood based on a turbidimetric and colorimetric test. The assay is composed of the following vials:
- 1 x 23 ml vial (R1) 1 x 23 ml vial (R2) 1 x 110 ml vial (R3) 2 x 21 ml vials (R4) 1 x 25 ml vial (R5)
Reagent R1 is prepared from substances of animal origin and purified with human material. Reagents R2 and R3 are prepared from substances of animal origin and chemical solutions. R4 and R5 are chemical solutions with additives.
The ABX PENTRA HbA1c Cal is a liquid multi-calibrator prepared from chemical solutions. It is used for the calibration of the HbA1c assays. The assigned values are given in the notice. This calibrator has six levels and is provided in one vial of 8 ml and five vials of 2 ml.
The ABX PENTRA HbA1c Control is a lyophilized assayed control prepared from human whole blood. It has 2 levels (Normal and Pathological) to be used for the quality control of HbA 1c assays. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 0.25 ml. The kit contains also a 2 ml reconstitution buffer vial.
The ABX PENTRA HbA1c WB Hemolysis Reagent is a chemical solution for use in the lysis of red blood cells with the HbA1c HORIBA ABX methods on the ABX Pentra 400 system. It is provided in a 110 ml vial.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
REAGENT
ABX PENTRA HbA1c WB (Hemolysate/Manual hemolysis method):
Sample type: Whole blood
Accuracy and Precision: CV Total
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. 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. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).
0
Premarket Notification [510(k)] Summary
OCT 1 7 2008
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
The assigned 510(k) number is : K073309
Company: Horiba ABX Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE + (33) 4 67 14 73 92 Telephone: + (33) 4 67 14 15 17 Fax:
Olivier Ducamp (oducamp(@fr.abx.fr) Contact Persons: Caroline Ferrer (cferrer(a)fr.abx.fr)
Date Prepared: 24th June 2008
Device Names:
The following reagents, controls & calibrators are for use in conjunction with the ABX PENTRA 400, cleared to market under K052007.
REAGENTS :
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA HbA1c WB
Hemoglobin Alc Class II §864.7470 : Glycosylated hemoglobin assay LCP ; Assay, Glycosylated hemoglobin
CALIBRATOR:
Trade/Proprietary Name: Common or Usual Name: Device Class Classification Name: Product Code:
ABX PENTRA HbA1c WB Cal
HbA1c Calibrator Class II $862.1150 : Calibrator JIX ; Calibrator, Multi-analyte mixture
1
| CONTROLS : | |
|---|---|
| Trade/Proprietary Name: | ABX PENTRA HbA1c WB Control |
| Common or Usual Name: | Hemoglobin A1c Control |
| Device Class | Class 1 |
| Classification Name: | §862.1660 : Quality control material (assayed) |
| Product Code: | JJY ; Multi-analyte controls (Assayed and Unassayed) |
| ADDITIONAL REAGENTS: | |
| Trade/Proprietary Name: | ABX PENTRA HbA1c WB Hemolysis Reagent |
| Common or Usual Name: | Hemolysis reagent |
| Device Class | Class 1 : Exempt from Premarket notification |
| Classification Name: | §862.8540 : Red cell lysing product |
| Product Code: | GGK : Products, Red-cell lysing products |
Substantial Equivalence:
The data and information supplied in this submission demonstrates substantial equivalence to their respective predicate devices :
| Submission device | Substantially equivalent
Predicate device |
|--------------------------|----------------------------------------------|
| ABX PENTRA HbAlc WB | K031380 (Olympus)
K955087 (Bayer) |
| ABX PENTRA HbA1c Cal | K031380 (Olympus)
K955087 (Bayer) |
| ABX PENTRA HbA1c Control | K031380 (Olympus)
K951361 (Bayer) |
Description:
All the reagents, controls and calibrators included in this submission are for use on the ABX PENTRA 400 (K052007), which is a discrete photometric benchtop clinical chemistry analyzer.
The ABX PENTRA HbA1c WB is an in vitro diagnostic assay for the quantitative determination of Hemoglobin A1c in human whole blood based on a turbidimetric and colorimetric test. The assay is composed of the following vials:
- 1 x 23 ml vial (R1) 1 x 23 ml vial (R2) 1 x 110 ml vial (R3) 2 x 21 ml vials (R4) 1 x 25 ml vial (R5)
2
Reagent R1 is prepared from substances of animal origin and purified with human material. Reagents R2 and R3 are prepared from substances of animal origin and chemical solutions. R4 and R5 are chemical solutions with additives.
The ABX PENTRA HbA1c Cal is a liquid multi-calibrator prepared from chemical solutions. It is used for the calibration of the HbA1c assays. The assigned values are given in the notice. This calibrator has six levels and is provided in one vial of 8 ml and five vials of 2 ml.
The ABX PENTRA HbA1c Control is a lyophilized assayed control prepared from human whole blood. It has 2 levels (Normal and Pathological) to be used for the quality control of HbA 1c assays. The assigned values are given in the enclosed annex. Each level of this calibrator is provided in two vials of 0.25 ml. The kit contains also a 2 ml reconstitution buffer vial.
The ABX PENTRA HbA1c WB Hemolysis Reagent is a chemical solution for use in the lysis of red blood cells with the HbA1c HORIBA ABX methods on the ABX Pentra 400 system. It is provided in a 110 ml vial.
Intended Use:
ABX Pentra HbA1c WB reagent is intended for use on the ABX PENTRA 400 for the quantitative in-vitro determination of HbA1c using whole blood and hemolysate. The controls, calibrators and additional reagents are intended for use in association with the above reagents.
3
Discussion of Performance Data:
REAGENT
| ABX PENTRA HbA1c WB (Hemolysate/Manual hemolysis method) : | ||
|---|---|---|
| Sample type | Whole blood | |
| Accuracy and Precision | CV Total |