(254 days)
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No
The document describes a calibration verification material for an in vitro diagnostic assay, which is a chemical reagent used for quality control. There is no mention of any computational or algorithmic processing that would involve AI or ML.
No
This device is for in vitro diagnostic use as a control for calibration verification of assays, not for treating a condition or disease.
No
Explanation: The device is described as "calibration verification material" for assays, which means it helps ensure the accuracy of diagnostic tests, but it does not directly diagnose a condition itself. It's a control material, not a diagnostic one.
No
The device description clearly indicates it is a physical product (vials containing liquid) used for in vitro diagnostic purposes, 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 "For in vitro diagnostic use as a control for calibration verification...". This is the primary indicator of an IVD.
- Function: The device is a "calibration verification material" used to check the accuracy of other in vitro diagnostic assays (IMMULITE® Unconjugated Estriol (uE3) assays). This function is directly related to ensuring the reliability of diagnostic testing performed outside of the body.
- Matrix: The material is "estriol in processed horse serum," which is a biological matrix used in laboratory testing.
- Device Description: The description details a product designed for use in a laboratory setting ("supplied in liquid form, ready to use," "Store unopened materials refrigerated," "for single use only, immediately after opening").
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For in vitro diagnostic use as a control for calibration verification of the IMMULITE® Unconjugated Estriol (uE3) assays on the IMMULITE 1000, 2000 systems.
The calibration verification material is assayed control with four levels. The analyte levels for IMMULITE 1000 are 0.00, 0.16, 2.70 and 11.2 ng/ml, and 0.00, 0.19, 2.90 and 12.00 for IMULITE 2000 systems. The matrix is estriol in processed horse serum.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
IMMULITE unconjugated Estriol assays are traceable to an internal standard and manufactured using qualified materials and measurement procedures. Calibration Verification Material (CVM) is traceable to this standard. For additional information, consult the assay instruction for use.
One set of four vials, 2 mL each, containing low, intermediate and high levels of unconjugated estriol in processed horse serum, with preservative, and an unconjugated estriol free sample. The calibration verification material (CVM) is supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. CVM's are for single use only, immediately after opening, and discard after use.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
The traceability, value assignment, and stability of the Calibration Verification Materials have been validated following procedures of Siemens Healthcare Diagnostics.
Analyte Levels/ Targets: IMMULITE® 1000: CVM 1 = 0.0 ng/mL, CVM 2 = 0.16 ng/mL, CVM 3 = 2.7 ng/mL, CVM 4 = 11.2 ng/mL. IMMULITE® 2000: CVM 1 = 0.0 ng/mL, CVM 2 = 0.19 ng/mL, CVM 3 = 2.9 ng/mL, CVM 4 = 12.0 ng/mL.
Matrix: Normal horse serum.
Constituents: Unconjugated Estriol spiked in normal horse serum, with 100 ppm Proclin 950 as a preservative.
Preparation method: The IMMULITE uE3 Calibration Verification Material levels contain Estriol spiked in normal horse serum and 100 ppm Proclin 950 as a preservative.
uE3 CVM Value Assignment: The uE3 reference calibrator values are assigned by using a panel of real serum samples from pregnancy patients which were value assigned by GC-MS. This reference calibrator lot was then used to assign values of uE3 CVM. The reference calibrator and CVM are run on both IMMULITE® 1000 and IMMULITE® 2000 systems. The average observed value for each CVM is used as their assigned value. Quality control is then performed by monitoring the recovery of controls.
Protocol: Production lots of calibration verification materials are value assigned against the reference calibrators using multiple reagent lots which are run on at least three different instruments.
Calculations: Calibration verification material values are derived using four-parameter weighted data algorithm reduction of the reference calibrator for each run on each instrument. Calibration verification material values are then averaged across all instruments.
CVM Release Ranges by Platform: IMMULITE/IMMULITE® 1000: CVM (ng uE3/mL) 0, Target μ (ng uE3/mL) 0, Range (ng uE3/mL) 0 - 0.07, Precision (% CV) NA; CVM (ng uE3/mL) 0.16, Target μ (ng uE3/mL) 0.16, Range (ng uE3/mL) 0.07 - 0.25, Precision (% CV)
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(K) Summary of Safety and Effectiveness
IMMULITE® Unconjugated Estriol (uE3) Calibration Verification Material
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.
A. 510(K) Number: K110061
B. Date of Preparation: September 14, 2011 (Revised)
C. Proprietary and Established Names:
IMMULITE® Unconjugated Estriol (uE3) Calibration Verification Material
Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Ernest Joseph, Regulatory Affairs Manager
Office: (914) 524-2431 Fax: (914) 524-2601
E. Regulatory Information:
IMMULITE® Calibration Verification Material, uE3
- Regulation section: 21 CFR § 862.1660
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- Classification: Class I
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- Product Code: JJX
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- Panel: Clinical Chemistry
F. Predicate Device:
The ADVIA Centaur® Enhanced Estradiol Master Curve Material is for in vitro diagnostic use in the verification of calibration and reportable Range in the ADVIA Centaur® Enhanced Estradiol (eE2) assay cleared under 510k number K102904.
G. Device Description:
IMMULITE unconjugated Estriol assays are traceable to an internal standard and manufactured using qualified materials and measurement procedures. Calibration
1
Verification Material (CVM) is traceable to this standard. For additional information, consult the assay instruction for use.
One set of four vials, 2 mL each, containing low, intermediate and high levels of unconjugated estriol in processed horse serum, with preservative, and an unconjugated estriol free sample. The calibration verification material (CVM) is supplied in liquid form, ready to use. Store unopened materials refrigerated at 2-8°C until expiration date. CVM's are for single use only, immediately after opening, and discard after use.
Statement of Intended Use:
For in vitro diagnostic use as a control for calibration of the IMMULITE® Unconjugated Estriol (uE3) assays on the IMMULITE/IMMULITE® 1000, and IMMULITE® 2000 systems.
Comparison to the Predicate Device: Similarities and Differences between the devices and the predicate are shown below:
| IMMULITE® Device | Predicate | |
|---|---|---|
| Item | IMMULITE® Calibration | |
| Verification Material | ||
| (K110061) | ADVIA Centaur® Master | |
| Calibration Material | ||
| (K102904) | ||
| Intended use | For in vitro diagnostic use as | |
| a control for calibration | ||
| verification of the IMMULITE | ||
| Unconjugated Estriol (UE3) | ||
| assays on the | ||
| IMMULITE/IMMULITE 1000, | ||
| IMMULITE 2000 systems. | The ADVIA ® Centaur | |
| Enhanced Estradiol Master | ||
| Curve Material is for in vitro | ||
| diagnostic use in the | ||
| verification of calibration | ||
| and reportable range in the | ||
| ADVIA Centaur® Enhanced | ||
| Estradiol (eE2) assay. | ||
| Assay | Estriol | Estradiol |
Similarities:
2
Differences:
| Item | Device | Device |
|---|---|---|
| IMMULITE® Calibration Verification Material | ||
| (K110061) | ADVIA Centaur® Master Calibration Material | |
| (K102904) | ||
| Form | Liquid | Lyophilized |
| Matrix | Estriol in processed horse serum | Estradiol in processed human serum |
| Number of Levels | 4 | 6 |
| Stability | Unopened -until expiration date on the label at 2-8 °C | Unopened - until expiration date on the label at 2-8°C |
| reconstituted - 14 days | ||
| on-board - 6 hours |
Performance:
The traceability, value assignment, and stability of the Calibration Verification Materials have been validated following procedures of Siemens Healthcare Diagnostics.
Analyte Levels/ Targets:
| Value Assignment Targeted Concentration of levels | |
|---|---|
| IMMULITE® 1000 | IMMULITE® 2000 |
| CVM 1 = 0.0 ng/mL | CVM 1 = 0.0 ng/mL |
| CVM 2 = 0.16 ng/mL | CVM 2 = 0.19 ng/mL |
| CVM 3 = 2.7 ng/mL | CVM 3 = 2.9 ng/mL |
3
CVM 4 = 11.2 ng/mL
CVM 4 = 12.0 ng/mL
Matrix:
Normal horse serum
Constituents:
Unconjugated Estriol spiked in normal horse serum, with100 ppm Proclin 950 as a preservative.
Preparation method:
The IMMULITE uE3 Calibration Verification Material levels contain Estriol spiked in normal horse serum and 100 ppm Proclin 950 as a preservative.
uE3 CVM Value Assignment:
The uE3 reference calibrator values are assigned by using a panel of real serum samples from pregnancy patients which were value assigned by GC-MS. This reference calibrator lot was then used to assign values of uE3 CVM. The reference calibrator and CVM are run on both IMMULITE® 1000 and IMMULITE® 2000 systems. The average observed value for each CVM is used as their assigned value. Quality control is then performed by monitoring the recovery of controls.
Protocol:
Production lots of calibration verification materials are value assigned against the reference calibrators using multiple reagent lots which are run on at least three different instruments.
Calculations:
Calibration verification material values are derived using four-parameter weighted data algorithm reduction of the reference calibrator for each run on each instrument. Calibration verification material values are then averaged across all instruments.
CVM Release Ranges by Platform:
| IMMULITE/IMMULITE® 1000 | ||||
|---|---|---|---|---|
| CVM | ||||
| (ng uE3/mL) | Target u | |||
| (ng uE3/mL) | Range | |||
| (ng uE3/mL) | Precision | |||
| (% CV) | ||||
| 0 | 0 | 0 - 0.07 | NA | |
| 0.16 | 0.16 | 0.07 - 0.25 |