Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunoturbidimetric assay and does not mention any AI or ML components. The performance studies are based on traditional statistical methods.

Therapeutic

No
The device is an in vitro diagnostic test used for aid in diagnosis, not for treating a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states that "Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism." This directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description clearly indicates a physical assay employing latex particles and turbidimetric measurement, which are hardware components and processes, not solely software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma". The phrase "in vitro" is a key indicator of an IVD.
Purpose: The intended use also states that the measurements are "used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings." This clearly indicates a diagnostic purpose.
Sample Type: The test is performed on "human serum and plasma," which are biological samples taken from the body, a characteristic of IVDs.
Device Description: The description details a laboratory test method (immunoturbidimetric test) performed on these samples.

All these elements align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the compatibility with potential recipients, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Immunological in vitro immunoturbidometric test for the quantitative determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.

Product codes (comma separated list FDA assigned to the subject device)

DBF

Device Description

The Tina-quant Ferritin Gen. 4 assay employs an immunoturbidimetric test in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 570/800 nm.

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)

Precision: Precision was determined using human samples and controls in accordance with the CLSI EP5 requirements.
Repeatability (Within run):
Sample: PNP, Mean ng/mL: 128, % CV: 0.9
Sample: PPP, Mean ng/mL: 332, % CV: 1.2
Sample: HS1, Mean ng/mL: 8.48, % CV: 7.2
Sample: HS2, Mean ng/mL: 25.5, % CV: 4.7
Sample: HS3, Mean ng/mL: 235, % CV: 0.9
Sample: HS4, Mean ng/mL: 619, % CV: 1.2
Sample: HS5, Mean ng/mL: 820, % CV: 1.1

Intermediate Precision - Between Day:
Sample: PNP, Mean ng/mL: 128, % CV: 1.5
Sample: PPP, Mean ng/mL: 332, % CV: 2.0
Sample: HS1, Mean ng/mL: 8.48, % CV: 9.9
Sample: HS2, Mean ng/mL: 25.5, % CV: 5.2
Sample: HS3, Mean ng/mL: 235, % CV: 1.8
Sample: HS4, Mean ng/mL: 619, % CV: 2.1
Sample: HS5, Mean ng/mL: 820, % CV: 2.1

Analytical Sensitivity: Limit of Blank = 3 ng/mL, Limit of Detection = 5 ng/mL
Functional Sensitivity: Limit of Quantitation = 7 ng/mL

Interferences:
Icterus: No significant interference up to an I index of 60 (approximate conjugated and unconjugated bilirubin concentration: 60 mg/dL).
Hemolysis: No significant interference up to an H index of 500 (approximate hemoglobin concentration: 500 mg/dL).
Lipemia (Intralipid): No significant interference up to an Intralipid concentration of 1000 mg/dL on Roche/Hitachi 912, 917 and MODULAR P analyzers and up to an Intralipid concentration of 800 mg/dL on Roche/Hitachi 902 analyzers. There is poor correlation between the Intralipid concentration (corresponds to turbidity) and triglycerides concentration.
Rheumatoid factors

Regulation Number and Section

§ 866.5340 Ferritin immunological test system.

(a)
Identification. A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.(b)
Classification. Class II (performance standards).

Summary

0

K100538

.

Tina-quant Ferritin Gen. 4 Assay

:

JUN 2 2 2010

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact	Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250
Phone: (317) 521 - 3831
Fax: (317) 521 - 2324
	Contact Person: Kathie Goodwin, Regulatory Principal
	Roche Diagnostics, Indianapolis
	Phone: 317-521-3831
	Fax: 317-521-2324
	Date Prepared: February 22nd, 2010
Device Name	Proprietary names: Tina-Quant Ferritin Gen. 4 Assay
	Common names: Ferritin Gen. 4 assay
	Regulation: 21 CFR 866.5340
	Classification names: Ferritin Immunological Test System
	Product codes: DBF
Device Description	The Tina-quant Ferritin Gen. 4 assay employs an immunoturbidimetric test in which human ferritin agglutinates with latex particles coated with anti-ferritin antibodies. The precipitate is determined turbidimetrically at 570/800 nm.
Intended use	In vitro test for the quantitative determination of ferritin in human serum and plasma on Roche automated clinical chemistry analyzers.
	Continued on next page

1

Immunological in vitro immunoturbidometric test for the quantitative Indications for Use determination of ferritin in human serum and plasma using Roche/Hitachi clinical chemistry analyzers. Measurements obtained by this device are used in the aid of diagnosis of diseases affecting iron metabolism in conjunction with other clinical and laboratory findings.

The Tina-quant Ferritin Gen. 4 assay is substantially equivalent to the Tina-Substantial equivalence Quant Ferritin assay cleared in K964282.

Substantial equivalence comparison

Feature	Tina-quant Ferritin Gen. 4 Assay	Predicate Device: Tina-Quant Ferritin (K964283)
Intended Use	In vitro test for the quantitative
determination of ferritin in human
serum and plasma on Roche
automated clinical chemistry
analyzers.	Immunoturbidimetric assay for the in
vitro quantitative determination of
ferritin in human serum and plasma
using automated clinical chemistry
analyzers.
Assay Protocol	Same	Immunoturbidimetric
Anti-ferritin antibodies bound to latex
react with the antigen in the sample to
form an antigen-antibody complex.
Following agglutination, this is
measured turbidimetrically.
Sample Type	Serum and Li-heparin, K2-EDTA or
K3-EDTA plasma	Serum and heparinized, citrated or K2
or K3-EDTA plasma

2

| Feature | Tina-quant Ferritin Gen. 4 Assay | Predicate Device: Tina-Quant
Ferritin (K964283) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Reagent
Composition | R1: TRIS Buffer, pH 7.5,
stabilizing polyclonal antibodies,
NaCl preservative | R1: TRIS Buffer, pH 8.2, stabilizing
polyclonal antibodies, NaCl
Preservative |
| | R3: Aqueous matrix containing
latex particles coated with anti-
human ferritin antibodies (rabbit);
preservative, stabilizers | R2: Aqueous matrix containing latex
particles coated with anti-human
ferritin antibodies (rabbit);
preservative, stabilizers |
| Labeled
Instrument
Platform | Roche/Hitachi | Roche/Hitachi |
| Calibrator | Same | C.f.a.s. Proteins |
| Calibration
Frequency | Same | After lot change and as required
following quality control procedures |
| Controls | Same | Precinorm and Precipath Protein |
| Reagent
Stability | Unopened: Up to stated expiration
date of 24 months | Unopened: Up to stated expiration
date of 15 months |
| | Opened:
84 days, refrigerated on the analyzer | Opened:
28 days, refrigerated on the analyzer |
| Measuring
Range | Roche/Hitachi 902:
5 - 800 ng/mL | Roche/Hitachi 902:
5 - 400 ng/mL |
| | Roche/Hitachi 912/917/Modular P:
5 - 1000 ng/mL | Roche/Hitachi 912/917/Modular P:
15 - 800 ng/mL |

3

Feature	Tina-quant Ferritin Gen. 4 Assay		Predicate Device: Tina-Quant Ferritin (K964283)
Precision	Precision was determined using human samples and controls in accordance with the CLSI EP5 requirements.		Imprecision: Reproducibility was determined using human samples and controls in an internal protocol: n=21. The following results were obtained.
		Repeatability
Within run	Intermediate Precision -
Between Day
	Sample	Mean
ng/mL	% CV	Mean
ng/mL	% CV	Sample	Mean
ng/mL	% CV	Mean
ng/mL	% CV
	PNP	128	0.9	128	1.5	HS	32	6.0	32	5.6
	PPP	332	1.2	332	2.0	PNP	77	2.5	76	2.7
	HS1	8.48	7.2	8.48	9.9	PPP	333	1.2	329	1.3
	HS2	25.5	4.7	25.5	5.2
	HS3	235	0.9	235	1.8
	HS4	619	1.2	619	2.1
	HS5	820	1.1	820	2.1
Analytical
Sensitivity	Limit of Blank = 3 ng/mL
Limit of Detection = 5 ng/mL
Functional
Sensitivity	Limit of Quantitation = 7 ng/mL					NA
Analytical
Specificity	Same					The polyclonal antibodies used in the assay are specific for ferritin from human liver and also recognize ferritin from human spleen. The antibodies show no cross reactivity to the human ferritin H subunit; which is the major component of human heart ferritin.

4

| Feature | Tina-quant Ferritin Gen. 4 Assay | Predicate Device: Tina-Quant
Ferritin (K964283) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Interferences | Icterus:
No Significant interference up to an I
index of 60 (approximate conjugated
and unconjugated bilirubin
concentration: 60 mg/dL) | Icterus:
No Significant interference up to an I
index of 60 (approximate conjugated and
unconjugated bilirubin concentration: 60
mg/dL) |
| | Hemolysis:
No significant interference up to an H
index of 500 (approximate hemoglobin
concentration: 500 mg/dL) | Hemolysis:
No significant interference up to an H
index of 500 (approximate hemoglobin
concentration: 500 mg/dL) |
| | Lipemia (Intralipid):
No significant interference up to an
Intralipid concentration of 1000 mg/dL
on Roche/Hitachi 912, 917 and
MODULAR P analyzers and up to an
Intralipid concentration of 800 mg/dL
on Roche/Hitachi 902 analyzers. There
is poor correlation between the
Intralipid concentration (corresponds to
turbidity) and triglycerides
concentration. | Lipemia (Intralipid):
No significant interference up to an L
index of 750 (approximate triglyceride
concentration: 1500 mg/dL). There is
poor correlation between turbidity and
triglyceride concentration. |
| | Rheumatoid factors