← Product Code [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN) · K142132

# POOL NORM (K142132)

_Diagnostics Stago S.A.S. · GGN · Dec 12, 2014 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K142132

## Device Facts

- **Applicant:** Diagnostics Stago S.A.S.
- **Product Code:** [GGN](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN.md)
- **Decision Date:** Dec 12, 2014
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5425
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Indications for Use

The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests: - APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers - dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers. This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.

## Device Story

Pool Norm is a lyophilized, citrated normal human plasma pool; used as a quality control reagent for APTT and dRVVT coagulation assays. Device is processed in clinical laboratories by certified medical laboratory personnel using automated analyzers (STA-R, STA Compact, STA Satellite). Users process the control in the same manner as patient samples. Output is a clotting time (seconds) or ratio, provided via a lot-specific Certificate of Analysis. Healthcare providers use these values to monitor assay performance and validate the accuracy of patient test results. Benefits include ensuring reliable coagulation testing and identifying potential analytical errors.

## Clinical Evidence

Bench testing only. Precision/reproducibility studies conducted across three sites using three lots of Pool Norm on STA-R, STA Compact, and STA Satellite analyzers. Results demonstrated acceptable within-run and within-laboratory precision (CV% typically <2%). Stability studies confirmed 8-hour open-vial stability at 20±5°C and 24-month real-time stability at 2-8°C. No clinical data required for this control reagent.

## Technological Characteristics

Lyophilized pool of at least 20 citrated normal human plasmas; includes buffers, stabilizers, and preservatives. Reconstituted for use. Analyzed via automated coagulation analyzers (STA-R, STA Compact, STA Satellite). Storage at 2-8 °C. No direct patient contact; no sterility or biocompatibility requirements.

## Regulatory Identification

A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

## Special Controls

*Classification.* Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

## Predicate Devices

- Pooled Normal Plasma (Pre-amendment device, George King Bio-Medical, INC)
- STA® - Control LA 1 ([K061803](/device/K061803.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM

A. 510(k) Number:
k142132

B. Purpose for Submission:
Clearance of a new human normal plasma control

C. Measurand:
Assayed control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT)

D. Type of Test:
Quantitative

E. Applicant:
Diagnostica Stago

F. Proprietary and Established Names:
Pool Norm

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5425, Multipurpose system for in vitro coagulation studies
2. Classification:
Class II
3. Product code:
GGN, Plasma, Coagulation Control
4. Panel:

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(81) Hematology

H. Intended Use:

1. Intended use(s):

The Pool Norm is a normal human plasma pool intended for use as a normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:

- APTT: STA® - PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers
- dRVVT: STA® - Staclot® dRVV Screen (REF 00339, 00333), STA® - Staclot® dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.

This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use.

2. Indication(s) for use:

Same as intended use

3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

- APTT: STA-R®, STA Compact® and STA Satellite® analyzers
- dRVVT: STA-R® and STA Compact® analyzers

I. Device Description:

Pool Norm is a lyophilized pool of at least 20 citrated normal human plasmas, containing buffer, stabilizers and preservatives.

Each blood donation is tested and found to be negative for the antibodies to HIV 1, HIV 2, HCV and for hepatitis B surface antigen.

The Pool Norm is to be used in the same manner as patients' samples. Users are asked to refer to the "Procedure" chapter of the package insert. The product is packaged in a box containing 12 x 1-mL vials.

J. Substantial Equivalence Information:

1. Predicate device name(s):

George King Bio-Medical, Inc. Pooled Normal Plasma

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Diagnostica Stago STA® – Control LA 1

2. Predicate 510(k) number(s):

George King Bio-Medical, Inc. Pooled Normal Plasma is a pre-amendment device. The Sponsor provided a copy of FDA determination letter concerning the pre-amendment status of the Pooled Normal Plasma from George King Bio-Medical, Inc.

k061803 (STA® – Control LA 1

3. Comparison with predicate:

|  Similarities |   |   |   |
| --- | --- | --- | --- |
|  Item | Device
Pool Norm
(Diagnostica Stago) | Predicate
Pooled Normal Plasma
(George King Bio-Medical) | Predicate
STA® – Control LA 1
(Diagnostica Stago)  |
|  Intended Use | Normal control for the activated partial thromboplastin time (APTT) and dilute Russell's viper venom time (dRVVT) assays carried out with the following tests:
APTT: STA® PTT A (REF 00595) on STA-R®, STA Compact® and STA Satellite® analyzers
dRVVT: STA® - Staclot®
dRVV Screen (REF 00339, 00333), STA® Staclot®
dRVV Confirm (REF 00334) on STA-R® and STA Compact® analyzers.
This reagent is to be used in clinical laboratories by certified medical laboratory personnel. For in vitro diagnostic use only. For prescription use. | Control plasma intended to be used to monitor coagulation tests.
For in vitro diagnostic use only. | Lupus anticoagulant (LA) negative plasma intended for the quality control of the tests for LA detection carried out with the following tests:
- STA® - Staclot®
dRVV Screen (REF 00339, 00333)
- STA® - Staclot®
dRVV Confirm (REF 00334)
- Staclot® LA (REF 00600, 00594).
For in vitro diagnostic use only.  |
|  Test procedure | Same manner as patients' samples | Same | Automatically used by the instruments  |
|  Matrix | Citrated human plasma from normal donors | Same | LA negative citrated human plasma  |

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|  Differences  |   |   |   |
| --- | --- | --- | --- |
|  Item | Device Pool Norm (Diagnostica Stago) | Predicate Pooled Normal Plasma (George King Bio-Medical) | Predicate STA® – Control LA 1 (Diagnostica Stago)  |
|  Assay values reporting | Lot-specific Certificate of Analysis (COA): - reporting assay values for Activated Partial Thromboplastin Time (APTT) - certifying negative testing for lupus anticoagulant | Lot-specific COA: - reporting assay values for Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, Factors V, VII, VIII, IX, X, XI and XII | Lot-specific COA: - reporting control values for STA® – Staclot® dRVV Screen, STA® – Staclot® dRVV Confirm and Staclot® LA  |
|  Storage | 2-8°C | ≤70°C | 2-8°C  |
|  Manufacturing process | Lyophilized pooled normal citrated human plasma | Frozen pooled normal citrated human plasma | Lyophilized  |
|  In-use stability | 8 hours at 20 ± 5°C | 2 hours after thawing at 37°C | 8 hours at 20 ± 5°C 8 hours on the STA® Compact® and STA-R®  |

# K. Standard/Guidance Document Referenced (if applicable):

CLSI EP05-A2; Evaluation of Precision Performance of Quantitative Measurement Methods, 2nd Edition

CLSI 25-A Evaluation of Stability of In Vitro Diagnostic Reagents: Approved Guideline

# L. Test Principle:

The Norm Pool is to be used the same manner as patients' samples in the STA®-PTT A assay and the Staclot® dRVV Screen and Staclot® dRVV Confirm assays.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

Repeatability study/Within-Laboratory Precision Study: Three lots of Pool Norm were tested in house for 20 days, in two runs per day and two replicates per run, by three operators using one lot of assay reagent. The following instrument/assay combinations were tested:

i. STA-R® and STA Compact®: STA® Staclot® dRVV Screen, STA® Staclot® dRVV Confirm (k061805)

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ii. STA-R®; STA Compact® and STA Satellite®: STA® PTT A (k861190)

Precision was also tested using three (3) lots of Pool Norm across all instruments according to the following design. One lot of PTT A assay was tested with three (3) lots of Norm Pool on the STA-R® and STA Compact® and STA Satellite®. One lot of dRVV Screen and one lot of dRVV Confirm were tested with three (3) lots of Norm Pool on the STA-R® and STA Compact® only. Within-laboratory SD and %CV, as well as total SD and %CV were calculated. Study results met the predetermined acceptance criteria.

## Reproducibility study

Reproducibility was conducted at three (3) sites - two external and one internal site. The same three (3) lots of Pool Norm and one (1) lot of assay reagent were tested across all sites, over five non-consecutive days including two runs per day, three (3) replicates per run and three (3) operators.

The coefficient of variation (CV) and the standard deviation (SD) for within-run, between-run, between-day and within-laboratory/total precision were calculated separately for each site and each lot. In addition, the CV and SD for within-run, between-run, between-day, between-lot and within-laboratory/total precision were calculated for combined data of three lots of Pool Norm.

For pooled data obtained on the STA-R® at three sites (combined data from the three lots), the CV% and SD for within-run, between-run, between-lot, between-day, between-site and total precision were also calculated.

Results show that data met predetermined acceptance criteria and demonstrated acceptable reproducibility of the Pool Norm under tested conditions. Test data are presented below:

on STA-R®

|  Assay | Sample Pool Norm Lot | N | X (sec) | Repeatability |   | Within-Laboratory Precision  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |   |  SD (sec) | CV (%) | SD (sec) | CV (%)  |
|  STA® - PTT A | 110150 | 80 | 33.1 | 0.3 | 1.0 | 0.6 | 1.7  |
|   |  110795 |   | 32.6 | 0.3 | 1.0 | 0.5 | 1.6  |
|   |  111289 |   | 32.5 | 0.3 | 0.9 | 0.5 | 1.5  |
|  STA® - Staclot® dRVV Screen | 110150 | 80 | 42.4 | 0.3 | 0.8 | 0.6 | 1.4  |
|   |  110795 |   | 41.6 | 0.2 | 0.6 | 0.5 | 1.3  |
|   |  111289 |   | 41.2 | 0.2 | 0.4 | 0.5 | 1.1  |
|  STA® - Staclot® dRVV confirm | 110150 | 80 | 38.2 | 0.3 | 0.8 | 0.5 | 1.3  |
|   |  110795 |   | 37.9 | 0.3 | 0.8 | 0.5 | 1.3  |
|   |  111289 |   | 37.7 | 0.3 | 0.7 | 0.4 | 1.1  |

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on STA Compact®

|  Assay | Sample Pool Norm Lot | N | X (sec) | Repeatability |   | Within-Laboratory Precision  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |   |  SD (sec) | CV (%) | SD (sec) | CV (%)  |
|  STA® - PTT A | 110150 | 80 | 33.0 | 0.5 | 1.6 | 0.7 | 2.1  |
|   |  110795 |   | 32.7 | 0.4 | 1.2 | 0.6 | 1.7  |
|   |  111289 |   | 32.5 | 0.5 | 1.5 | 0.7 | 2.1  |
|  STA® - Staclot® dRVV Screen | 110150 | 80 | 40.5 | 0.3 | 0.7 | 0.6 | 1.6  |
|   |  110795 |   | 40.0 | 0.3 | 0.7 | 0.6 | 1.4  |
|   |  111289 |   | 39.4 | 0.4 | 0.9 | 0.7 | 1.8  |
|  STA® - Staclot® dRVV confirm | 110150 | 80 | 37.0 | 0.3 | 0.9 | 0.5 | 1.4  |
|   |  110795 |   | 36.5 | 0.5 | 1.4 | 0.7 | 1.9  |
|   |  111289 |   | 36.4 | 0.4 | 1.0 | 0.5 | 1.4  |

on STA Satellite®

|  Assay | Sample Pool NormLot | N | X (sec) | Repeatability |   | Within-Laboratory Precision  |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |   |   |  SD (sec) | CV (%) | SD (sec) | CV (%)  |
|  STA® - PTT A | 110150 | 80 | 33.5 | 0.1 | 0.4 | 0.3 | 0.9  |
|   |  110795 |   | 33.1 | 0.1 | 0.2 | 0.3 | 0.9  |
|   |  111289 |   | 33.1 | 0.1 | 0.3 | 0.3 | 0.9  |

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

## Stability study

The open-vial stability and real-time stability claims were verified using STA®-PTT A and STA®-Staclot® dRVV Screen and STA®-Staclot dRVV Confirm on the STAR® analyzer. Three (3) lots of Pool Norm (three vials per lot) at each time point were tested. The acceptance criteria for open-vial and real time stability were ≤ 5% and ≤ 10%, respectively. The results met the acceptance criteria and supported open-vial stability of 8 hours at 20±5°C and real-time stability for 24 months at 2-8°C.

## Value assignment

Value assignment for the Pool Norm was based on data for both APTT and dRVVT assays. Testing was performed in triplicate using 3 different lots of assay reagent yielding 27 values. The determinations were carried out on a minimum of 3 analyzers and by a minimum of 2 laboratory technicians over a minimum two days. The

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averaged clotting times obtained yielded a value of 31-35 seconds.

For dRVVT assays the final result is expressed as a ratio of mean clotting time of the Pool Norm and clotting time of the reference pool. Obtained results yielded a ratio range of 0.99-1.01.

d. Detection limit:
Not applicable

e. Analytical specificity:
Not applicable

f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:
Not applicable

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
A lot-specific Certificate of Analysis will be provided with each kit of the Pool Norm. The clotting time for STA®-PTT A will be reported in seconds. The reference value for dRVVT will be reported as ratio of mean clotting time of the Pool Norm and clotting time of the reference pool. The ratio less than 1.20 is reported as negative on the Certificate of Analysis.

7

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N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K142132](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GGN/K142132)

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